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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
148129–148152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1985
ECONOMY 400 CWS WITH PVC DRAINS
K851084 · GCY
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Jun 04, 1985
INCISION DRAIN
K851196 · GCD
Sil-Med Corp.
General & Plastic Surgery · 70d
Cleared Jun 04, 1985
BAC-T-SCREEN
K851399 · JXA
Marion Laboratories, Inc.
Microbiology · 56d
Cleared Jun 04, 1985
S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
K851421 · LPH
Joint Medical Products Corp.
Orthopedic · 55d
Cleared Jun 04, 1985
HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE
K851648 · EJS
Heraeus Dental Gold Corp.
Dental · 43d
Cleared Jun 04, 1985
PROSTHESIS OR SURGICAL PADS
K851668 · GBI
Virginia Hall, Inc.
General & Plastic Surgery · 42d
Cleared Jun 04, 1985
QUALITONE STOCK CANAL AID
K851970 · ESD
Qualitone
Ear, Nose, Throat · 28d
Cleared Jun 04, 1985
LYFO-KWIK OMI KIT
K851978 · JSS
Micro-Bio-Logics
Microbiology · 28d
Cleared Jun 04, 1985
DRI-FORM PSEUDOMONAS AGAR F
K852064 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Jun 04, 1985
IDS RAPID E PLUS SYSTEM
K852110 · JSS
Innovative Diagnostic Systems, Inc.
Microbiology · 20d
Cleared Jun 04, 1985
ELECTRO-CAUTERY KNIFE CLEANER 6000 1
K852184 · HAM
Dlp, Inc.
General & Plastic Surgery · 15d
Cleared Jun 04, 1985
MCCOY GENCELLS
K852204 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
RMK GENCELLS CULTURE SYSTEM
K852205 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
HEP-2 GENCELLS
K852206 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
CELLGRO
K852288 · KIT
Mediatech, Inc.
Pathology · 6d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843940 · KWA
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950 · KWA
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
INTEGRITY EYE DROP GUIDE
K851908
Integrity Optics, Inc.
Ophthalmic · 33d
Cleared Jun 03, 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994 · CIT
Alpkem Corp.
Chemistry · 27d
Cleared Jun 03, 1985
PENNINE DERBY YANKAUER
K852079 · BSY
Pennine Medical , Ltd.
Anesthesiology · 21d
Cleared Jun 03, 1985
PENNINE SUCTION CATHETERS
K852080 · BSY
Pennine Medical , Ltd.
Anesthesiology · 21d
Cleared Jun 03, 1985
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500
K852150 · HRM
Keeler Instruments, Inc.
General & Plastic Surgery · 17d
Cleared May 31, 1985
EVOMATIC 8000/4000
K843815 · GWF
Dantec Electronics, Inc.
Neurology · 245d
Cleared May 31, 1985
CORNEAL LIGHT SHIELD
K850270 · HRM
Mentor O & O, Inc.
General & Plastic Surgery · 128d