1988
4,299 FDA 510(k) clearances · Clearance year
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| Record | Firm | Date |
|---|---|---|
| HEART CHECK APOLIPOPROTEIN-B (K881433) | Northwest Biotech | 1988-04-21 |
| OLYMPIA ALLOY (K881333) | J.F. Jelenko & Co., Inc. | 1988-04-21 |
| MODIFIED PARACON(TM) CONCENTRATION KIT (K881649) | Para Scientific Co. | 1988-04-21 |
| ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM (K875244) | Diagnostic Products Corp. | 1988-04-21 |
| VEOLAR VENTILATOR (K871792) | Hamilton Medical, Inc. | 1988-04-21 |
| KIN-COM JR (K881388) | Chattanooga Group, Inc. | 1988-04-21 |
| TISSUE SECTION ADHESIVE (K881659) | Surgipath Medical Industries, Inc. | 1988-04-21 |
| TDX (R) AMPHETAMINE CLASS (K874770) | Abbott Laboratories | 1988-04-21 |
| GOLDENROD ALLERGEN DISC (K875163) | Incstar Corp. | 1988-04-21 |
| QM300 CALIBRATOR D PACK (K881127) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-04-21 |
| AXILLARY BLOCK NEEDLE (K880970) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-04-21 |
| KODAK SURECELL STREP A TEST KIT (K881457) | Eastman Kodak Company | 1988-04-21 |
| ORTHODONTIC NITINOL SPRINGS (K881331) | Flexmedics | 1988-04-21 |
| SERODOT TOXOPLASMA IGG TEST KIT (K875363) | Disease Detection International, Inc. | 1988-04-21 |
| CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 (K881062) | Cobe Laboratories, Inc. | 1988-04-21 |
| NOVA LITE(TM) ANA PLUS (K881339) | Inova Diagnostics, Inc. | 1988-04-21 |
| CRYOBIOLOGICAL FREEZER (K881465) | Cryodyne Technologies, Inc. | 1988-04-21 |
| ANKLE REFLEX TREATMENT UNIT (ARTU) (K873658) | Universal Gym Equipment, Inc. | 1988-04-21 |
| RICH-MAR G1000 EMS (K880948) | Rich-Mar Corp. | 1988-04-21 |
| MESQUITE ALLERGEN DISC (K880415) | Incstar Corp. | 1988-04-21 |
| EXPANDOVER ELASTIC BANDAGE (K880207) | Expandover C/O Hale and Dorr | 1988-04-21 |
| HEART CHECK APOLIPOPROTEIN A-1 (K881434) | Northwest Biotech | 1988-04-21 |
| FOLDING WHEELCHAIR (K881452) | Health Care Innovations, Inc. | 1988-04-21 |
| FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 (K880038) | Sigma Diagnostics, Inc. | 1988-04-21 |
| SAFECATH (K880260) | Phase Medical Systems, Inc. | 1988-04-19 |
| EMIT VANCOMYCIN ASSAY (K881040) | Syva Co. | 1988-04-19 |
| OPHTHALMIC SPECTACLE LENS BLANKS (K881225) | Beta Optical Co, Inc. | 1988-04-19 |
| SS-1000 POLYGRAPH (K872520) | Meramed Corp. | 1988-04-19 |
| DECALCIFYING SOLUTION II (K881359) | Stephens Scientific | 1988-04-19 |
| SUN SHELL (SUN TANNING BED) (K881409) | Indoor Sun Systems, Inc. | 1988-04-19 |
| MICROTRAK CMV CULTURE CONFIRMATION TEST (K880290) | Syva Co. | 1988-04-19 |
| MTI WOLFF SYSTEM, TANNING BED (K881492) | Health Systems Intl., Inc. | 1988-04-19 |
| AMYLASE 405 CATALOG NUMBER 301-34 (K880867) | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-19 |
| JAMES TENDOS (SYRINGE HOLDER) (K875297) | Med-Text Intl. | 1988-04-19 |
| CSPI SPECIMEN TRAP (NON-STERILE) (K870874) | Custom Surgical Products, Inc. | 1988-04-19 |
| SPIRIX(TM) (K881427) | Medical/Surgical Specialties, Ltd. | 1988-04-19 |
| BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 (K880863) | New England Surgical Instrument Corp. | 1988-04-19 |
| MODEL 2001 PHACOEMULSIFIER ASPIRATOR (K880968) | Mcghan Instrumed Corp. | 1988-04-19 |
| HALF HOUR INFUSOR (K880625) | Baxter Healthcare Corp | 1988-04-19 |
| ABBOTT IMX T3 (K880087) | Abbott Laboratories | 1988-04-18 |
| HEMOGLOBIN POWDER (K881566) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| G-CERA PORCELAIN BOND (K880765) | G-C Intl. Corp. | 1988-04-18 |
| OF BASAL MEDIUM (K881550) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| RAJAH (K881354) | J.F. Jelenko & Co., Inc. | 1988-04-18 |
| CASMAN MEDIUM BASE (K881527) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| AMIES TRANSPORT MEDIUM (K881539) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE AGAR (K881558) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRICHOMONAS BROTH (K881556) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SABOURAUD MALTOSE AGAR (K881570) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CELL-CULTURE SHAKER (K881466) | Cryodyne Technologies, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR (K881534) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| XL AGAR BASE (K881572) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CALCIUM, CATALOGUE NUMBER 122-20 (K881054) | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 |
| ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (K880809) | Cooper Lasersonics, Inc. | 1988-04-18 |
| ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (K880807) | Cooper Lasersonics, Inc. | 1988-04-18 |
| DEXTROSE TRYPTONE BROTH (K881523) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BLOOD AGAR BASE W/LOW PH (K881532) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LABCO LIMITED EXETAINER(R) (K880622) | Labco, Ltd. | 1988-04-18 |
| SIM 4000C (K874548) | Ote-Biomedica Elettronica S.P.A | 1988-04-18 |
| YM BROTH (K881571) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DNASE TEST AGAR (K881486) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTONE (K881557) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR (K881536) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PLASTIC PRIMER (K880792) | Reliance Orthodontic Products, Inc. | 1988-04-18 |
| HEART INFUSION AGAR (K881542) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ALKALINE PHOSPHATASE REAGENT, DEA BUFF (K880796) | Trace America, Inc. | 1988-04-18 |
| TRYPTOSE PHOSPHATE BROTH (K881563) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY (K881124) | Nichols Institute Diagnostics | 1988-04-18 |
| ILLUMINA 40 CO2 LASER SYSTEM (K880427) | Cooper Lasersonics, Inc. | 1988-04-18 |
| KENSEY CATHETER (K880194) | Theratek, Inc. | 1988-04-18 |
| PORCELAIN PRIMER (K880790) | Reliance Orthodontic Products, Inc. | 1988-04-18 |
| HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (K881477) | Stat Path | 1988-04-18 |
| MYCOLOGICAL AGAR W/LOW PH (K881549) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DEXTROSE AGAR (K881522) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. (K880795) | Trace America, Inc. | 1988-04-18 |
| MALT EXTRACT (K881545) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CHAPMAN STONE MEDIUM (K881526) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ALBUMIN CAT. # 201-03 (K875207) | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 |
| TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ACID PHOSPHATASE REAGENT (K880798) | Trace America, Inc. | 1988-04-18 |
| JETPOLISHER AIRPOLISHING POWDER (K875339) | Young Dental Manufacturing Co. 1, LLC | 1988-04-18 |
| UREA AGAR BASE (K881559) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO (K880619) | Syva Co. | 1988-04-18 |
| SKIM MILK DEHYDRATED (K881554) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHYTONE YEAST EXTRACT AGAR (K881573) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY (K881512) | Wescor, Inc. | 1988-04-18 |
| COOKED MEAT MEDIUM (K881525) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CARY AND BLAIR TRANSPORT MEDIUM (K881529) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE BLOOD AGAR BASE (K881562) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MALT EXTRACT AGAR (K881546) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STREPTOSEL (K881578) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| WILKENS CHALGREN BROTH (K881568) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STUARTS TRANSPORT MEDIUM (K881569) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SELENITE BROTH (K881576) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CAPCADDY (K880621) | Capcad, Inc. | 1988-04-18 |
| MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT (K880934) | Amersham Corp. | 1988-04-18 |
| PROTEOSE NO. 3 AGAR (K881552) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| THE ESI-2000 ULTRASOUND UNIT (K874683) | Elscint, Inc. | 1988-04-18 |
| RUSSELL DOUBLE SUGAR AGAR (K881553) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BLOOD AGAR BASE NO. 2 (K881533) | Acumedia Manufacturers, Inc. | 1988-04-18 |
Track 1988 automatically
Every clearance here is in the API, with alerts when new ones post.