FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86185–86208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991703 · GCJ
Stryker Instruments
General & Plastic Surgery · 8d
Cleared May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER...
K981246 · JXG
Integra Neurocare, LLC
Neurology · 415d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN...
K983805 · LFX
Zeus Scientific, Inc.
Microbiology · 210d
Cleared May 26, 1999
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN...
K984120 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN...
K984135 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
DIGI-SNAP
K984169 · MNR
Snap Laboratories, LLC
Anesthesiology · 187d
Cleared May 26, 1999
TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
K984497 · FLL
Oriental System Technology, Inc.
General Hospital · 160d
Cleared May 26, 1999
QUANTEC-E ENDO SYSTEM
K990739 · EKX
Sybron Dental Specialties, Inc.
Dental · 82d
Cleared May 26, 1999
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K990963 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 64d
Cleared May 26, 1999
SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K991415 · LYY
Supermax Sdn Bhd
General Hospital · 33d
Cleared May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 30d
Cleared May 26, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K991493 · LZA
Masju Sdn. Bhd.
General Hospital · 28d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · DQO
Cordis Corp.
Cardiovascular · 9d
Cleared May 25, 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 120d
Cleared May 25, 1999
VITRON M
K990763 · EBI
Espe Dental AG
Dental · 78d
Cleared May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
K990978 · CJW
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
BUN, MODEL BU 104-01
K990980 · CDQ
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL...
K990981 · CFR
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · KHS
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · CGX
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO....
K991111 · CIC
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · JMO
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247 · KNK
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK),...
K991386 · CEP
Selfcare, Inc.
Chemistry · 34d