| REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. (K880013) | Abbott Laboratories | 1988-03-01 |
| PHARMACLUSIVE (TM) (K872573) | Pharmacia, Inc. | 1988-02-29 |
| TYPE 316L STAINLESS STEEL WIRE (K880309) | Winn Hirsch & Assoc. | 1988-02-29 |
| PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (K875095) | Pall Biomedical Products Co. | 1988-02-29 |
| SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT (K874450) | Surgitech C/O Collier, Shannon, Rill & Scott | 1988-02-29 |
| EDEC 60R (K880050) | Electromed Intl., Ltd. | 1988-02-29 |
| ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (K875094) | Pall Biomedical Products Co. | 1988-02-29 |
| PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM (K873526) | Pall Safety Atmospheres, Inc. | 1988-02-29 |
| FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR (K880394) | Intertech/Ohio | 1988-02-29 |
| SCIMED INFLATION DEVICE, MODEL SM 2000 (K875064) | Scimed Life Systems, Inc. | 1988-02-29 |
| ELECTRONIC EPILATOR (K880553) | Clareblend, Inc. | 1988-02-29 |
| OLYMPUS ANGIOSCOPY SHEATH (K873100) | Olympus Corp. | 1988-02-29 |
| ASTHMAKIT (K874047) | Dhd Medical Products Div. Diemolding Corp. | 1988-02-29 |
| PREFILLED WATER FOR IRRIGATION USP (K880316) | Automatic Liquid Packaging, Inc. | 1988-02-29 |
| GUARDIAN, EEG BRAIN MONITORING SYSTEM (K874733) | Tracor Northern, Inc. | 1988-02-29 |
| OVERHEAD TUBE MOUNT CASCADE II (K880528) | Fischer Imaging Corp. | 1988-02-29 |
| VAN-TEC ENDOPYELOTOMY KNIFE (K880094) | Van-Tec, Inc. | 1988-02-29 |
| PHASE II (K875142) | Reliance Orthodontic Products, Inc. | 1988-02-29 |
| CAL/RAD UPGRADE MODEL 1030 (K880272) | Sun Nuclear Corp. | 1988-02-29 |
| PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP (K880317) | Automatic Liquid Packaging, Inc. | 1988-02-29 |
| AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* (K875090) | United States Surgical, A Division of Tyco Healthc | 1988-02-29 |
| ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT (K875091) | Mission White Dental, Inc. | 1988-02-29 |
| DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE (K880411) | Dey Laboratories, Inc. | 1988-02-29 |
| BREATHE-FREE (K875073) | Cincinnati Medical Technologies, Inc. | 1988-02-29 |
| NON-INVASIVE BLOOD PRESSURE MODULE (K875265) | Ppg Industries, Inc. | 1988-02-29 |
| AIR VENT LINE CAT. NO. AVL-36 (K875080) | American Omni Medical, Inc. | 1988-02-29 |
| BIOSURGE MODEL ILVC-1 (K875016) | Biosurge, Inc. | 1988-02-29 |
| RESUSCITATOR (K874567) | American Medical Technology, Inc. | 1988-02-29 |
| CIBA CORNING BALANCED HEPARIN FOR CA++ (K875117) | Ciba Corning Diagnostics Corp. | 1988-02-29 |
| LIBERATOR 53/STROLLER 50 (K880101) | Minnesota Valley Engineering, Inc. | 1988-02-29 |
| CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM (K880527) | Fischer Imaging Corp. | 1988-02-29 |
| HI FLOW PORTABLE LIQUID OXYGEN UNIT (K875352) | Minnesota Valley Engineering, Inc. | 1988-02-29 |
| RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) (K875143) | Reliance Orthodontic Products, Inc. | 1988-02-26 |
| SUNGLASSES (NONPRESCRIPTION) (K873966) | Swank Plus , Ltd. | 1988-02-26 |
| ADDVANTAGE:TVC MARCON (K880284) | Richards Medical Co., Inc. | 1988-02-26 |
| OKAMOTO CONDOMS (K880202) | Schmid Laboratories, Inc. | 1988-02-26 |
| HOSKINS-BARKAN GONIOTOMY LENS 10MM (K875330) | Ocular Instruments, Inc. | 1988-02-26 |
| PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 (K875308) | Self Regulation Systems, Inc. | 1988-02-26 |
| EXCEL FAST SET (K875144) | Reliance Orthodontic Products, Inc. | 1988-02-26 |
| DECHERNEY HYSTEROSCOPY PUMP SYSTEM (K873527) | Cabot Medical Corp. | 1988-02-26 |
| P2020 MOBILE C-ARM IMAGE INTENSIFIER (K874905) | Photo Medic Equipment, Inc. | 1988-02-26 |
| SPECTACLE, MAGNIFYING (K873967) | Swank Plus , Ltd. | 1988-02-26 |
| LIDO(TM) LIFT (K880017) | Loredan Biomedical, Inc. | 1988-02-26 |
| MAR BOND (K875145) | Reliance Orthodontic Products, Inc. | 1988-02-26 |
| TORONTO/MOBILIMB HAND C.P.M. (K880686) | Toronto Medical Corp. | 1988-02-26 |
| INFRAGUIDE(TM) (K875115) | Cooper Lasersonics, Inc. | 1988-02-26 |
| SURGICAL BURS (K880706) | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 |
| BISCOLOR (K875256) | Bisco, Inc. | 1988-02-26 |
| DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC (K875242) | Driskell Bioengineering | 1988-02-26 |
| LABTICIAN RETINAL IMPLANTS (K875014) | Labtician Products, Inc. | 1988-02-26 |
| RUBBER CONTRACEPTIVE, LATEX CONDOMS (K875111) | Okamoto USA, Inc. | 1988-02-26 |
| ALKALINER (K873882) | Espe GmbH (Us) | 1988-02-26 |
| DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC (K875243) | Driskell Bioengineering | 1988-02-26 |
| BICONCAVE VITRECTOMY LENS (K875331) | Ocular Instruments, Inc. | 1988-02-26 |
| EXCEL REGULAR SET (K875141) | Reliance Orthodontic Products, Inc. | 1988-02-26 |
| REPLICARE (K880299) | United Medical | 1988-02-26 |
| VENT CORP PIB IMPLANT (K873818) | Core-Vent Corp. | 1988-02-26 |
| LIDO(TM) WORKSET (K880018) | Loredan Biomedical, Inc. | 1988-02-26 |
| BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (K873673) | Sonicaid, Inc. | 1988-02-26 |
| IR-192 IMPLANT (K874895) | Rads S.L., Inc. | 1988-02-25 |
| MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 (K880001) | 3M Company | 1988-02-25 |
| MODIFIED SONICATOR 720, MODEL ME720 (K880602) | Mettler Electronics Corp. | 1988-02-25 |
| MODIFIED CRP LATEX TEST (K880016) | Sclavo, Inc. | 1988-02-25 |
| EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339) | Em Diagnostic Systems, Inc. | 1988-02-25 |
| LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K880444) | Bio-Rad | 1988-02-25 |
| SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11 (K874767) | Shimadzu Precision Instruments, Inc. | 1988-02-25 |
| PROGENE(TM) IGE TEST (K875125) | Progene Corp. | 1988-02-25 |
| UROSTHESIA (K880342) | Medical Research Innovators, Inc. | 1988-02-25 |
| IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ (K874491) | Y | 1988-02-25 |
| ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (K873082) | Cambridge Bioscience Corp. | 1988-02-24 |
| HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS (K880650) | Baxter Healthcare Corp | 1988-02-24 |
| VIRGO(TM) MEASLES IGG ELISA (K873925) | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 |
| MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG (K874911) | Walter Lorenz Surgical, Inc. | 1988-02-24 |
| CARETEX SURGEON'S CAPS (K880481) | James River Corp. | 1988-02-24 |
| CART, MULTIPURPOSE (K880539) | Ferguson Medical | 1988-02-24 |
| AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 (K880039) | Sigma Diagnostics, Inc. | 1988-02-24 |
| EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (K880029) | Immuno-Mycologics, Inc. | 1988-02-24 |
| KODAK EKTACHEM DT SLIDES (LIPA) (K875173) | Eastman Kodak Company | 1988-02-24 |
| KODAK EKTACHEM DT SLIDES (CRSC) (K875191) | Eastman Kodak Company | 1988-02-24 |
| MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION (K874798) | Xylog Corp. | 1988-02-24 |
| INTELECT VMS 2, OR INTELECT VMS II (K880234) | Chattanooga Group, Inc. | 1988-02-24 |
| IMAGEN INFLUENZA VIRUS A AND B TESTMI (K872958) | Boots-Celltech Diagnostics, Inc. | 1988-02-24 |
| CART, INSTRUMENT (K880536) | Ferguson Medical | 1988-02-24 |
| ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (K873312) | Cambridge Bioscience Corp. | 1988-02-24 |
| DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (K875102) | Bio-Rad | 1988-02-24 |
| CARETEX SURGEON'S HOODS (K880431) | James River Corp. | 1988-02-24 |
| KODAK EKTACHEM DT SLIDES (CKMB) (K875192) | Eastman Kodak Company | 1988-02-24 |
| BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (K875248) | Bioscan Instruments, Inc. | 1988-02-24 |
| LIGHT, SURGICAL, FLOOR STANDING (K880540) | Ferguson Medical | 1988-02-24 |
| OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP (K880286) | Richards Medical Co., Inc. | 1988-02-23 |
| RIONET HEARING AID HB-75 (K874510) | Rion Acoustic Instruments, Inc. | 1988-02-23 |
| IN-THE-EAR HEARING AID (K875010) | Statco Hearing Aid Laboratory | 1988-02-23 |
| SERIES S415/S425 - BEHIND-THE-EAR HEARING AID (K880466) | Maico Hearing Instruments, Inc. | 1988-02-23 |
| PERIODONTAL SCALING SOLUTION-C (K875150) | Dentsply Intl. | 1988-02-23 |
| AMPLAID 309 CLINICAL AUDIOMETER (K880059) | Amplus Corp. | 1988-02-23 |
| PERIDONTAL SCALING SOLUTION-B (K875149) | Dentsply Intl. | 1988-02-23 |
| RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP (K880285) | Richards Medical Co., Inc. | 1988-02-23 |
| PERIODONTAL SCALING SOLUTION-A (K875132) | Dentsply Intl. | 1988-02-23 |
| SERIES S515/S525 BEHIND-THE-EAR HEARING AID (K880465) | Maico Hearing Instruments, Inc. | 1988-02-23 |
| BAXTER BEDSIDE SYSTEM (K874181) | Travenol Laboratories, S.A. | 1988-02-22 |