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
116281–116304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400 · MID
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401 · MID
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 20, 1992
VISTA HPQ SYSTEM
K920714 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 184d
Cleared Aug 20, 1992
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA
K921140 · JXO
Solarcare Technologies Corp,Inc.
Toxicology · 163d
Cleared Aug 20, 1992
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA
K921328 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 155d
Cleared Aug 20, 1992
IMAGICA MICRO-ENDOSCOPE
K921393 · EOQ
Fiberoptic Medical Products, Inc.
Ear, Nose, Throat · 150d
Cleared Aug 20, 1992
AL-ACID GLYCOPROTEIN RID KIT
K922417 · LKL
The Binding Site, Ltd.
Immunology · 91d
Cleared Aug 20, 1992
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 85d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
K922680 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 77d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · JHY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 77d
Cleared Aug 20, 1992
PULPDENT HARD CORE
K922755 · EBF
Pulpdent Corp.
Dental · 72d
Cleared Aug 20, 1992
BIOSTARS STREP A OIA -- MODIFICATION
K922765 · GTY
Biosearch Medical Products, Inc.
Microbiology · 79d
Cleared Aug 20, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 72d
Cleared Aug 20, 1992
WAKO IGG-HA
K923070 · CFN
Wako Chemicals USA, Inc.
Immunology · 56d
Cleared Aug 19, 1992
GUIDEWIRES, VARIOUS TYPES
K920884 · DQX
Acme-Monaco Corp.
Cardiovascular · 230d
Cleared Aug 19, 1992
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 112d
Cleared Aug 19, 1992
ARRAY(R) 360
K922273 · JQX
Beckman Instruments, Inc.
Chemistry · 97d
Cleared Aug 19, 1992
GRASPING FORCEPS
K922542 · FGO
Surgitek
Gastroenterology & Urology · 82d
Cleared Aug 18, 1992
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
K915512 · JWH
Pfizer Hospital Products Group, Inc.
Orthopedic · 253d
Cleared Aug 18, 1992
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)
K920295 · DQK
Oxford Medilog, Inc.
Cardiovascular · 209d
Cleared Aug 18, 1992
SURGEON'S GOWN
K920404 · FYC
Amsco Sterile Recoveries, Inc.
General Hospital · 200d
Cleared Aug 18, 1992
STERILE SURGEON'S GOWN
K920405 · FYA
Amsco Sterile Recoveries, Inc.
General Hospital · 200d
Cleared Aug 18, 1992
DUODERM SUSTAINED COMPRESSION BANDAGE
K920675 · KGX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 186d
Cleared Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
K921223 · GFO
Analytical Control Systems, Inc.
Hematology · 158d