Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NOVA GEL(TM) SM/RNP (K881181)Inova Diagnostics, Inc.1988-04-06
CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) (K872356)Mayer Laboratories1988-04-06
SM ANTIBODY TEST KIT (K880254)Lipogen, Inc.1988-04-06
INTRAFORM TOTAL HIP SYSTEM (K880390)Orthomet, Inc.1988-04-05
ALBUMIN REAGENT SET (K880844)Tech-Neal Scientific, Inc.1988-04-05
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT (K880743)Abbott Laboratories1988-04-05
I.M.A. RETRACTOR (K881159)T. Korossurgical Instruments Corp.1988-04-05
GLYCO-PROBE GSP (K873428)Isolab, Inc.1988-04-05
DRUG MIXTURE CONTROL IN URINE (K880512)Eastern Laboratories, Ltd.1988-04-05
XYLENE (K881282)Anatech, Ltd.1988-04-05
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY (K880678)Ventrex Laboratories, Inc.1988-04-05
PROFECT SURGEONS' GLOVES (K880535)Network Trading Corp.1988-04-05
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR (K881156)T. Korossurgical Instruments Corp.1988-04-05
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT (K880410)Disease Detection International, Inc.1988-04-05
ANIMAL AND HUMAN SERA (K881287)Cell Culture Laboratories1988-04-05
CREATININE REAGENT SET (KINETIC) (K880843)Tech-Neal Scientific, Inc.1988-04-05
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER (K880949)Advanced Biomedical Methods, Inc.1988-04-05
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (K880177)Tech-Co, Inc.1988-04-05
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL (K875135)Syva Co.1988-04-05
DISPOSABLE STERILE LATEX SURGICAL GLOVES (K881069)Komin Trading Co.1988-04-05
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (K875079)Miles Laboratories, Inc.1988-04-05
FIRST RESPONSE 5 MINUTE PREGNANCY TEST (K874823)Tambrands, Inc.1988-04-05
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K880445)Bio-Rad1988-04-05
LDH-L REAGENT SET (K880842)Tech-Neal Scientific, Inc.1988-04-05
CALCIUM REAGENT SET (K880845)Tech-Neal Scientific, Inc.1988-04-05
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 (K881254)Norfolk Scientific, Inc.1988-04-05
ABBOTT IMX HTSH (K880086)Abbott Laboratories1988-04-05
BOVINE CALF SERUM SUPPLEMENTED #A-2159 (K880471)Hyclone Laboratories, Inc.1988-04-04
NOVO VIVO MODEL #17140 AND #17135 (K880377)Genesis Industries, Inc.1988-04-04
MCT 8000 (MULTI-VISION CONTRAST TESTER) (K881059)Vistech Consultants, Inc.1988-04-04
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER (K880507)Coulter Electronics, Inc.1988-04-04
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (K881243)Labsystems, Inc.1988-04-04
FRAME, SPECTACLE (K873965)Swank Plus , Ltd.1988-04-01
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 (K874816)Kontron Instruments, Inc.1988-04-01
PYR/ESCULIN DISK (K880950)Remel Co.1988-04-01
REGAL LATEX SURGICAL GLOVES (K881191)Maxcare, Inc.1988-04-01
GUIDE WIRE INTRODUCER (K873972)Target Therapeutics1988-04-01
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (K880855)Richard James, Inc.1988-04-01
TEGASORB ULCER DRESSING #90-XXX (K872298)3M Company1988-04-01
NON ADHERENT PAD (K880788)Cederroth, Inc. USA1988-04-01
CALIFORNIA CONVERTIBLES (SUNGLASSES) (K880709)Jmj World Trade Corp.1988-04-01
CIRCADIAN STRESS TEST II (K874641)Circadian, Inc.1988-04-01
DIACYTE FIXATIVE SOLUTION (K880549)Cytocorp, Inc.1988-04-01
BREATHGUARD APNEA MONITOR (K872833)Lada Intl., Inc.1988-04-01
VCTS 700S SYSTEM (K881021)Vistech Consultants, Inc.1988-04-01
DUODERM(R) CGF (K881050)Convatec, A Division of E.R. Squibb & Sons1988-04-01
COBE CML3 (K880021)Cobe Laboratories, Inc.1988-04-01
KOI(TM) BLADE GAUGE, MODEL KOI-132 (K881094)CooperVision, Inc.1988-04-01
VCTS 6500 SYSTEM (K881023)Vistech Consultants, Inc.1988-04-01
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE (K880947)Lakewood Biochemical Co., Inc.1988-04-01
VCTS MARKETING PROGRAM SYSTEM (K881022)Vistech Consultants, Inc.1988-04-01
NUTRIENT GELATIN - PRODUCT NUMBER T2860 (K880946)Lakewood Biochemical Co., Inc.1988-04-01
MULTISURFACE ROLLER BOTTLE (M.S.R.B.) (K880509)Motil Plastics , Ltd.1988-04-01
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR (K880052)Baxter Healthcare Corp1988-04-01
WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY (K880544)Wescor, Inc.1988-04-01
EASY SHIELD ADHESIVE BANDAGE (K880675)Eye Garter Company, Inc.1988-04-01
BOVINE CALF SERUM CATALOG #A-2119 (K880470)Hyclone Laboratories, Inc.1988-04-01
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (K880647)Fred Sammons, Inc.1988-04-01
SITE SOLUTION ADMINISTRATION SET (K874725)Site Microsurgical Systems, Inc.1988-04-01
MASCOT STETHOSCOPE PROBE (K874726)Imex Medical Systems, Inc.1988-03-31
LOWENSTEIN-JENSEN, SELECTIVE (K880125)Hardy Media1988-03-31
TRANSRECTAL PROBE BD65S-TR (K880219)Elscint, Inc.1988-03-31
HEATER WIRE BREATHING CIRCUIT (K873179)Life Design Systems, Inc.1988-03-31
MIDDLEBROOK 7H9 BROTH (K880122)Hardy Media1988-03-31
UTILITY WAX STRIPS, SPEARMINT (K880607)Columbus Dental Mfg. Co.1988-03-31
VZV TEST (K875358)Gull Laboratories, Inc.1988-03-31
EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (K880596)Sigma Chemical Co.1988-03-31
MOELLERS DECARBOXYLASE, BASE (K880121)Hardy Media1988-03-31
MIDDLEBROOK 7H11 AGAR (K880134)Hardy Media1988-03-31
CHICOPEE ADULT INCONTINENCE SHIELDS (K880338)Chicopee, Inc.1988-03-31
AXIAL TOME, 60, FLUORO AND TOMAX (K872825)Axialtome Corp.1988-03-31
TRI-STAGE (TS-I) DENTAL IMPLANT (K880220)Tri-Stage, Inc.1988-03-31
LAURYL TRYPTOSE BROTH (K880126)Hardy Media1988-03-31
PROTEQ SURGEON'S GLOVES (K880632)Strategic Materials Group1988-03-31
CELL-DYN ISOTONIC DILUENT (K881130)Abbott Diagnostics1988-03-31
ALLERGIST SYRINGES (K880894)Abco Dealers, Inc.1988-03-31
MEDICOMP STRAIGHT SWIVEL ADAPTOR (K880434)Medicomp, Inc.1988-03-31
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER (K880422)Cardiac Control Systems, Inc.1988-03-31
LOWENSTEIN-JENSEN, W/NACL (K880124)Hardy Media1988-03-31
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 (K880079)A&D Engineering, Inc.1988-03-31
WHEEL-CHAIR W/MOTOR DRIVE (K880707)Paul Weiser Co.1988-03-31
LOWENSTEIN-JENSEN, GRUFT (K880131)Hardy Media1988-03-31
CO2/02 MONITOR MULTINEX (K872024)Datascope Corp.1988-03-31
'HILT-WAY' RESUSCITATOR (K880241)Medifield , Ltd.1988-03-31
MOELLERS DECARBOXYLASE, LYSINE (K880120)Hardy Media1988-03-31
MOELLERS DECARBOXYLASE, ONITHINE (K880119)Hardy Media1988-03-31
INDISTRIP (STERILIZATION PROCESS INDICATOR) (K875193)Indilab, Inc.1988-03-31
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE (K880393)Unitek Corp.1988-03-31
SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (K874668)Irvine Scientific1988-03-31
LOWENSTEIN-JENSEN SLANT (K880123)Hardy Media1988-03-31
AERO-MIST NEBULIZER HEATER (K880473)Pegasus Research Corp.1988-03-31
MRVP BROTH (K880116)Hardy Media1988-03-31
LAKE DISPOSABLE PROBE COVER (K880578)Lake Medical Products, Inc.1988-03-31
EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM (K880691)Sigma Chemical Co.1988-03-31
MIL MEDIUM (K880133)Hardy Media1988-03-31
OF MEDIUM BASE (K880117)Hardy Media1988-03-30
BHI WITH C & C SLANT (K880137)Hardy Media1988-03-30
CORN MEAL W/POLYSORBATE 80 (K880108)Hardy Media1988-03-30
WALLENSTEIN MEDIUM SLANT (K880138)Hardy Media1988-03-30
MULLER HINTON BROTH (K880105)Hardy Media1988-03-30
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Every clearance here is in the API, with alerts when new ones post.