FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96937–96960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1996
PATIENT EXAMINATION GLOVE (POWDERED)
K954293 · LYY
Medline Products Co. , Ltd.
General Hospital · 316d
Cleared Jul 26, 1996
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968 · JIL
Tcpi, Inc.
Chemistry · 273d
Cleared Jul 26, 1996
WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND,...
K955792 · GEI
Wilo Medizintechnik Lothar Wilberg GmbH
General & Plastic Surgery · 217d
Cleared Jul 26, 1996
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K955844 · JAQ
Varian Assoc., Inc.
Radiology · 213d
Cleared Jul 26, 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
K960800 · CGN
Boehringer Mannheim Corp.
Chemistry · 150d
Cleared Jul 26, 1996
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
K961287 · KDQ
Rocket Medical Plc
General Hospital · 114d
Cleared Jul 26, 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K961639 · HAW
Elekta Instrument AB
Neurology · 88d
Cleared Jul 26, 1996
MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
K961704 · ELS
Dentatus USA , Ltd.
Dental · 85d
Cleared Jul 26, 1996
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
K961742 · FQO
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 81d
Cleared Jul 26, 1996
MEDLITE/ERBIUM LASER SYSTEM
K961748 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 81d
Cleared Jul 26, 1996
BI-LOC BIPOLAR CUP
K961793 · KWY
Ortho Development Corp.
Orthopedic · 78d
Cleared Jul 26, 1996
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · GLK
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jul 26, 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · HWE
Stryker Corp.
Orthopedic · 67d
Cleared Jul 26, 1996
HYPODERMIC JET INJECTION APPARATUS
K962017 · EGM
American Jet Injector Corp.
Dental · 64d
Cleared Jul 26, 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jul 26, 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jul 26, 1996
PRECISION QID BLOOD GLUCOSE TEST STRIP
K962295 · CGA
Medisense, Inc.
Chemistry · 71d
Cleared Jul 26, 1996
TAKI DISPOSABLE ACUPUNCTURE NEEDLE
K962787 · MQX
Acupuncture Supplies Import Co.
General Hospital · 9d
Cleared Jul 25, 1996
HANC NETWORK
K952979 · DXN
Healthtech Services Corp.
Cardiovascular · 394d
Cleared Jul 25, 1996
MEDCOMP P-CATH
K953811 · FOZ
Medcomp
General Hospital · 365d
Cleared Jul 25, 1996
FORMULA IV ELECTRIC MOBILITY VEHICLE
K954378 · INI
Aerotek
Physical Medicine · 310d
Cleared Jul 25, 1996
PISTON SYRINGE
K955606 · FMF
Medical Surgical Intl.
General Hospital · 230d
Cleared Jul 25, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL...
K955828 · MKJ
Graphic Controls Corp.
Cardiovascular · 212d
Cleared Jul 25, 1996
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE...
K960278 · JDI
Zimmer, Inc.
Orthopedic · 188d