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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL) (K800745)Remel Co.1980-05-02
FERRO-QUANT TM FE 59 TEST KIT (K800868)Mallinckrodt Critical Care1980-04-29
ANTICONVULSANTS TOXICOLOGY CONTROL (K800882)Utak Laboratories, Inc.1980-04-29
AUTO-FIELD D AUTOMATED VISUAL DETECTOR (K800722)Cavitron Corp.1980-04-29
PREMIER ABSORBENT POINTS (K800827)Premier Dental Products Co.1980-04-29
PREMIER TRIPLE TRAY (K800900)Premier Dental Products Co.1980-04-29
CARDIACS II TOXICOLOGY CONTROL (K800884)Utak Laboratories, Inc.1980-04-29
OMNISTIK, MQ 501GS (K800860)Marquest Medical Products, Inc.1980-04-29
BARBITURATES TOXICOLOGY CONTROL (K800885)Utak Laboratories, Inc.1980-04-29
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL (K800886)Utak Laboratories, Inc.1980-04-29
PHADEBACT STREP D TEST (K800159)Pharmacia, Inc.1980-04-29
RADIOEAR MODEL RM-L & RM-C HEARING AID (K800567)Radioear Corp.1980-04-29
NICKERSON'S MED. SELECTIVE CULTURE MEDIU (K800754)Ortho Pharmaceutical Corp.1980-04-29
HYPNOTICS PLUS SALICYLATE TX CONTROL (K800887)Utak Laboratories, Inc.1980-04-29
MX820-5 PRESSURE INFUSOR 500CC MX820-10 (K800560)Medex, Inc.1980-04-29
CARDIACS I TOXICOLOGY CONTROL (K800883)Utak Laboratories, Inc.1980-04-29
STERILE SPONGE BOWLS (K800440)Premium Plastics, Inc.1980-04-29
TRICYCLIC ANTIDEPRESSANT II TX CONTROL (K800889)Utak Laboratories, Inc.1980-04-29
BELTLESS MAXI, MINI & SUPER MAXI PADS (K800747)Dafoe & Dafoe, Inc.1980-04-29
ADT DISPOSABLE THIN NEEDLE ASPIRATION (K800418)A.D.T. Lab Industries1980-04-28
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL (K800417)A.D.T. Lab Industries1980-04-28
ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW (K800412)A.D.T. Lab Industries1980-04-28
ADT SOFT TISSUE BIOPSY TRAY (K800414)A.D.T. Lab Industries1980-04-28
ADT BONE MARROW BIOPSY ASPIRATION TRAY (K800409)A.D.T. Lab Industries1980-04-28
ADT BONE MARROW BIOPSY-ASPIRATION TRAY (K800410)A.D.T. Lab Industries1980-04-28
ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE (K800408)A.D.T. Lab Industries1980-04-28
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (K800411)A.D.T. Lab Industries1980-04-28
GAS PAK II DIS. GENERATOR ENVELOPES (K800796)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-24
RIONET &/OR RION HEARING AID MODEL HA-82 (K800739)Rion Acoustic Instruments, Inc.1980-04-24
CORN MEAL AGAR MEDIA (K800807)Isle Media and Sterile Products, Inc.1980-04-24
SERALYZER URIC ACID REAGENT STRIPS - (K800848)Miles Laboratories, Inc.1980-04-24
RIONET &/OR RION HEARING AID MOD. HB-67S (K800738)Rion Acoustic Instruments, Inc.1980-04-24
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST (K800769)Sclavo, Inc.1980-04-24
MEDSPEC OPERATIVE OPTHALMIC KIT (K800404)Medi-Spec1980-04-24
SERIES 602 CKGTM RECORDER (K800851)Cardio Kinetics, Inc.1980-04-24
CENTRIFICHEM CHOLESTEROL (K800765)Union Carbide Corp.1980-04-24
CHLAMYDOSPORE AGAR (K800818)Isle Media and Sterile Products, Inc.1980-04-24
MISER INHALATION DEVICE, PART NO. 700 (K800763)Vix Breathing Equipment Co.1980-04-24
PRE-DENT SYSTEM (K800736)Pre-Dent System1980-04-24
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE (K800623)Pilling Co.1980-04-24
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL (K800813)Diagnostic Products Corp.1980-04-24
RAPI/TEX ASO STANDARD SERUM (K800642)Calbiochem-Behring Corp.1980-04-24
URI-DIP (R) (K800626)Pharma-Medica of Scandinavia, Ltd.1980-04-24
PRE-PADDED PLASTER/PARIS BAND/SPLINTS (K800752)Ortho-Care, Inc.1980-04-21
TESTOK-125 (K800776)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
FETAL BOVINE SERUM (K800781)Biolabs, Inc.1980-04-21
FELDMAN MINI-SAW, #300000 (K800669)KARL STORZ Endoscopy-America, Inc.1980-04-21
DUNRICH TABLES (K800756)Dunrich, Inc.1980-04-16
CODE QAS.105 PROLACTIN CONTROL SERA (K800708)Amersham Corp.1980-04-16
SNYDER HEMOVAC TM VENTED WOUND KIT (K800577)Snyder Laboratories, Inc.1980-04-16
MODEL 100 SPECTRAVIEW (K800655)Edwards Laboratories1980-04-16
SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP (K800511)American Convertors Div., American Pharmaseal1980-04-16
PROLACTIN RIA KIT (K800740)Amersham Corp.1980-04-16
SHIELD PERFECT FIT; DURA-FIT, DISPOS. (K800528)American Convertors Div., American Pharmaseal1980-04-16
SNYDER HYSTERECTOMY Y TUBE KIT (K800543)Snyder Laboratories, Inc.1980-04-16
AMES LAB MANAGEMENT SYSTEM (K800724)Miles Laboratories, Inc.1980-04-16
NORSEN DEBRIDER (K800647)Medline Industries, Inc.1980-04-16
MICROMEDIC AUTOMATIC DILUTER (K800606)Micromedic Systems1980-04-16
SURGIVAC TM (K800578)Snyder Laboratories, Inc.1980-04-16
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (K800357)Ortho Diagnostics, Inc.1980-04-16
U-STYLE ADAPTER (K800735)American Midwest1980-04-10
HYDRAGAMMA 16 (K800601)Innotron of Oregon, Inc.1980-04-10
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D (K800604)Beckman Instruments, Inc.1980-04-10
SEARS ALL-IN-THE-EAR HEARING AID #8149HF (K800447)Int'L Hearing Aids, Inc.1980-04-08
PROBE (K800729)Stainless Mfg., Inc.1980-04-08
RETROGRADE KNIFE (K800730)Stainless Mfg., Inc.1980-04-08
SEARS ALL-IN-THE-EAR HEARING AID #8149 (K800446)Int'L Hearing Aids, Inc.1980-04-08
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE (K800539)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-08
BETA-ASE TUBES (K800579)Microchemical Specialities, Co.1980-04-08
SUR-FIT UROSTOMY POUCH & URINARY BAG (K800495)E. R. Squibb & Sons, Inc.1980-04-08
DOUBLE-EDGE CURETTE (K800733)Stainless Mfg., Inc.1980-04-08
RUDD-CLINIC HEMORRHOIDAL FORCEPS (K800441)J. Sklar Mfg. Co., Inc.1980-04-08
MENISCOTOME (K800732)Stainless Mfg., Inc.1980-04-08
MENISCAL SAW (K800731)Stainless Mfg., Inc.1980-04-08
CAMPYLOBACTER AGAR W/5-ANTIMICROBICS (K800541)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-04
TLS TM SURGICAL DRAINAGE SYSTEM (K800581)Glasrock Products, Inc.1980-04-04
3M DISPOSABLE SKIN STAPLER (K800535)3M Company1980-04-04
KDA MICRO CHEMICAL ANALYZER (K800572)American Monitor Corp.1980-04-02
LIPASE DETERMINATION (K800550)The Dow Chemical Co.1980-04-02
100 ML SNYDER HEMOVAC (K800542)Snyder Laboratories, Inc.1980-04-02
MT-10, ET-20 (K800251)Associated Mills, Inc.1980-04-02
NEUROMETRICS MONITOR (K800452)Neurometrics1980-04-02
SURE FLOW TUBING (K800664)B & F Medical Products, Inc.1980-04-02
OXIDE ANAEROBIC SYSTEM (K800430)Oxoid U.S.A., Inc.1980-04-02
FERRIS MODIFIED DISP. IL STERNAL-ILIAC (K800413)A.D.T. Lab Industries1980-03-25
ADT NERVE BLOCK TRAY(DISP.) (K800423)A.D.T. Lab Industries1980-03-25
ADT MENGHINI TYPE SOFT TISSUE BIOPSY (K800415)A.D.T. Lab Industries1980-03-25
OXYGEN CATHETER (K800506)Medi-Craft , Ltd.1980-03-25
MICRO ELISA AUTO READER (K800522)Dynatech Laboratories, Inc.1980-03-25
SERTROL PRODUCT # ACS ST 101 (K800559)Analytical Control Systems, Inc.1980-03-25
LIPID CONTROL PRODUCT # ACS LC 101 (K800558)Analytical Control Systems, Inc.1980-03-25
AXIOM VESSEL LOOPS (K800015)Axiom Medical, Inc.1980-03-25
HMB-200 (K800250)Associated Mills, Inc.1980-03-25
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. (K800320)Amersham Corp.1980-03-25
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 (K800489)Atc Medical Technology, Inc.1980-03-25
ADT PERITONEAL LAVAGE TRAY (DISP.) (K800421)A.D.T. Lab Industries1980-03-25
ADULT ANESTHESIA BREATHING CIRCUITS . . (K800498)Airlife, Inc.1980-03-25
PEDIATRIC ANESTHESIA BREATHING CIRCUITS (K800499)Airlife, Inc.1980-03-25
DIFFERENTIAL REFRACTIVE INDEX DETECTOR (K800556)Hewlett-Packard Co.1980-03-25
CONNECTING TUBES (K800509)Medi-Craft , Ltd.1980-03-25
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