| REFLOTRON BILIRUBIN (K872818) | Boehringer Mannheim Corp. | 1987-11-23 |
| PARAMAX AMYLASE REAGENT (K873520) | Baxter Healthcare Corp | 1987-11-23 |
| MODEL 500E INFANT MONITORING SYSTEM (K873791) | Ge Medical Systems Information Technologies | 1987-11-23 |
| VAN DELLEN ASPIRATING TUBING (K873463) | Van Dellen, Ltd. | 1987-11-23 |
| TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS (K873183) | Abbott Laboratories | 1987-11-23 |
| BICARBONATE (K874435) | Boehringer Mannheim Corp. | 1987-11-23 |
| PARAMAX PHOSPHORUS REAGENT (K873454) | Baxter Healthcare Corp | 1987-11-23 |
| INFUSION MANIFOLD (K873852) | Advanced Surgical Products, Inc. | 1987-11-23 |
| TITAN GEL REP CPK-6 HV (K874144) | Helena Laboratories | 1987-11-23 |
| DISPOSABLE BIPOLAR FORCEPS (K873978) | E.M. Adams | 1987-11-23 |
| TUMORIMETER (K874352) | Cancer Technologies, Inc. | 1987-11-23 |
| S3 MEDICATED GAUZE (K874219) | Surgical Specialties, Inc. | 1987-11-23 |
| REVISED LABELING FOR OPIATES (K874485) | Abbott Laboratories | 1987-11-23 |
| VAN DELLEN CANNULA (K873464) | Van Dellen, Ltd. | 1987-11-23 |
| TAPERED PUNCH (K874357) | Med-Tool, Inc. | 1987-11-23 |
| REVISED LABELING FOR TDX CANNABINOIDS (K874488) | Abbott Laboratories | 1987-11-23 |
| MODIFIED PARAMAX GLUCOSE REAGENT (K873936) | Baxter Healthcare Corp | 1987-11-23 |
| PRECINORM L (K874230) | Boehringer Mannheim Corp. | 1987-11-23 |
| SKIN PREP ANALYZER (K874327) | Marquette Electronics, Inc. | 1987-11-23 |
| WAKO(TM) FE C (K874263) | Wako Chemicals USA, Inc. | 1987-11-23 |
| MICROTEK MINI-MAX DRILL SYSTEM (K874535) | Microtek Medical, Inc. | 1987-11-23 |
| REVISED LABELING FOR TDX BARBITURATES (K874483) | Abbott Laboratories | 1987-11-23 |
| REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS (K874376) | Syva Co. | 1987-11-23 |
| MAMEX DC S SL10/MG14 (K874040) | Orion Corp. | 1987-11-23 |
| REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (K873832) | In Vitro Diagnostics, Inc. | 1987-11-23 |
| IMSI, VITAL CALL (K873612) | Intl. Management Services, Inc. | 1987-11-23 |
| THER-A-PULSE (K872970) | Westec Corp. | 1987-11-23 |
| TORAY ANTHRON ANGIOGRAPHIC CATHETERS (K872983) | Toray Industries (America), Inc. | 1987-11-20 |
| BINAX EQUATE STREP B (K872904) | Binax, Inc. | 1987-11-20 |
| AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK (K874256) | Organon Teknika Corp. | 1987-11-20 |
| PLATELET EXTRACT REAGENT (K873382) | Bio/Data Corp. | 1987-11-20 |
| TX-4(TENS) (SIGMA TENS) (K874550) | Oms Medico, Inc. | 1987-11-20 |
| DYNATECH MR 250 MANUAL MICROELISA READER (K874598) | Dynatech Laboratories, Inc. | 1987-11-20 |
| TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 (K874538) | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| CLEARFIL PHOTO BOND (K872959) | Kuraray Co. | 1987-11-20 |
| NICOLET DISPOSABLE PRASS PROBE (K873964) | Nicolet Biomedical Instruments | 1987-11-20 |
| KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (K874537) | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| SOFT TISSUE ANCHORING SET KIT (K874439) | Concept, Inc. | 1987-11-20 |
| GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564) | Genetic Systems Corp. | 1987-11-20 |
| TX-2(TENS) (K874333) | Oms Medico, Inc. | 1987-11-20 |
| LAKE WOUND CARE/TREATMENT KIT (K873973) | Lake Medical Products, Inc. | 1987-11-20 |
| LUBRICATED CONDOM (K872504) | Royal American Industries, Inc. | 1987-11-20 |
| SPERMICIDAL CONDOM (K874464) | Royal American Industries, Inc. | 1987-11-20 |
| REVISED LABELING FOR CANNABINOIDS TEST KIT (K874269) | Roche Diagnostic Systems, Inc. | 1987-11-20 |
| PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL (K874304) | Phonic Ear, Inc. | 1987-11-20 |
| MODEL A-70, BEHIND-THE-EAR HEARING AID (K874323) | Audiotone, Inc. | 1987-11-20 |
| EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 (K873809) | Zimmer Aspen Labs | 1987-11-20 |
| PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (K873545) | Commercial Products & Engineering Co. | 1987-11-20 |
| ACRYLIC BASE DENTURE MATERIALS (K873738) | E&D Dental Manufacturing Co. | 1987-11-20 |
| THE EXTRACTOR(TM) (K873932) | Molecular Biosystems, Inc. | 1987-11-20 |
| CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA (K873384) | Helena Laboratories | 1987-11-20 |
| CIPROFLOXACIN 5 MCG SENSI-DISC (K874425) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-11-20 |
| KTP/532 LASER (K873330) | Laserscope | 1987-11-18 |
| SELECT SHOULDER SYSTEM (K873679) | Intermedics Orthopedics | 1987-11-17 |
| DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (K872006) | Mac Lee Medical Products | 1987-11-17 |
| STAINLESS 22-13-5 SUTURE WIRE (K873645) | Zimmer, Inc. | 1987-11-17 |
| RICH-MAR CONDUCTIVE GEL (K872036) | Rich-Mar Corp. | 1987-11-17 |
| BLOOD CONTAINMENT PACK (K872448) | Professional Medical Services | 1987-11-17 |
| COMFEEL ULCUS ULCER CARE SYSTEM (K873669) | Coloplast A/S | 1987-11-17 |
| POIRIER KID-ROLLER MANUAL WHEELCHAIR (K874317) | Roseburg SA | 1987-11-17 |
| EDENTEC MULTI-CHANNEL RECORDER (K873081) | Edentec Corp. | 1987-11-17 |
| HYPERTHERM TECHNOLOGIES' HEAT COMPRESS (K873364) | Hypertherm Technologies, Inc. | 1987-11-17 |
| PLASTIC TUBING CONNECTOR (K874360) | American Medical Technology, Inc. | 1987-11-17 |
| SURFACE TEMPERATURE SCANNER (K873010) | Omega Medical Corp. | 1987-11-17 |
| ABCOM 1 CARDIAC OUTPUT MONITOR (K870857) | Applied Biometrics, Inc. | 1987-11-16 |
| OMNI DIAGNOST (K874113) | Xre Corp. | 1987-11-16 |
| CHROME-COBALT BASE DENTAL ALLOY (K873661) | North American Alloys, Inc. | 1987-11-16 |
| TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (K872931) | Teca, Inc. | 1987-11-16 |
| OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES (K873284) | Litton Systems, Inc. | 1987-11-16 |
| TRAUMA TABLE II (K874114) | Xre Corp. | 1987-11-16 |
| MODEL A-17, BEHIND-THE-EAR HEARING AID (K874324) | Audiotone, Inc. | 1987-11-16 |
| MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE (K871579) | Sharplan Lasers, Inc. | 1987-11-16 |
| STEREOTIX (K873618) | Thomson-Cgr Medical Corp. | 1987-11-16 |
| FETAL SCALP ELECTRODE (K872057) | Medical Accessories, Inc. | 1987-11-16 |
| CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) (K873683) | Pentron Corp. | 1987-11-16 |
| INSUFFLATOR TUBING (K872860) | Medline Industries, Inc. | 1987-11-16 |
| REVISED LABELING FOR LSD TEST KIT (K874270) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (K873287) | Todd Medical, Inc. | 1987-11-13 |
| REVISED LABELING FOR BENZODIAZEPINE TEST KIT (K874265) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| REVISED LABELING FOR METHAQUALONE TEST KIT (K874272) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90 (K873575) | Healthcare Technologies, Inc. | 1987-11-13 |
| REVISED LABELING FOR AMPHETAMINE TEST KIT (K874274) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (K874342) | Cox-Uphuff Intl. | 1987-11-13 |
| KEELER CTU CRYO SYSTEM (K873388) | Keeler Instruments, Inc. | 1987-11-13 |
| REVISED LABELING FOR PCP TEST KIT (K874267) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| REVISED LABELING FOR ABUSCREEN EIA BARBITURATE (K874210) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| SURGICAL PREP RAZOR (K874370) | Derma-Safe Co. | 1987-11-13 |
| INFUSE-A-PORT ADDITIONAL SIZES (K872329) | Shiley Infusaid, Inc. | 1987-11-13 |
| ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN (K874213) | E.I. Dupont DE Nemours & Co., Inc. | 1987-11-13 |
| EMIT TOBRAMYCIN ASSAY (K874223) | Syva Co. | 1987-11-13 |
| REVISED LABELING FOR MORPHINE TEST KIT (K874268) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 (K874243) | Pilling Co. | 1987-11-13 |
| REVISED LABELING FOR COCAINE/COCAINE META. TEST (K874271) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| REVISED LABELING FOR BARBITURATE TEST KIT (K874266) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| REVISED LABELING FOR AMPHETAMINE TEST KIT (K874273) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS (K872039) | Life-Tech Intl., Inc. | 1987-11-13 |
| CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) (K872145) | Cryo Corp. | 1987-11-13 |
| NOVO BMC-LAB 23, BONE DENSITOMETER (K864299) | Scan Detectronic Laboratories, Inc. | 1987-11-12 |
| HEARING AID (ALL-IN-THE-EAR) (K873490) | Kerr Hearing Aid Laboratory | 1987-11-12 |
| TITANIUM SUCTION TIP (K874401) | Implant Innovations International, Inc. | 1987-11-12 |