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
148681–148704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1985
SURGIMED - SURGICAL BLADES
K851157 · GES
Surgimed Corp.
General & Plastic Surgery · 34d
Cleared Apr 25, 1985
DISSECTING TWEEZER #283-72PCS. SS 410
K851170 · GEN
The Huxley Instrument Corp.
General & Plastic Surgery · 34d
Cleared Apr 25, 1985
CATHETER CARE TRAY
K851179 · KOD
Pace Pharmaceutical Services, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 25, 1985
IRRIGATION TRAY
K851180 · KOD
Pace Pharmaceutical Services, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 25, 1985
SHOULDER-HOLDER
K851206
Biodynamic Technologies, Inc.
Orthopedic · 30d
Cleared Apr 25, 1985
ACTIVE DHEA-SULFATE DSL3500
K851239 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d
Cleared Apr 25, 1985
ATAC 2000 CHEMISTRY ANALYZER
K851321 · JQP
Turpen Laboratory Systems, Inc.
Chemistry · 23d
Cleared Apr 25, 1985
DISSCAP 110 DIALYZER
K851380 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 17d
Cleared Apr 25, 1985
4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL
K851529 · CAI
Sigma Medical, Inc.
Anesthesiology · 9d
Cleared Apr 25, 1985
4003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS
K851530 · CAI
Sigma Medical, Inc.
Anesthesiology · 9d
Cleared Apr 25, 1985
4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG
K851531 · CAI
Sigma Medical, Inc.
Anesthesiology · 9d
Cleared Apr 24, 1985
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · GQN
Cordis Corp.
Microbiology · 211d
Cleared Apr 24, 1985
LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
K850394 · DWS
Vascutech, Inc.
Cardiovascular · 82d
Cleared Apr 24, 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · FMI
Churchill Corp.
General Hospital · 79d
Cleared Apr 24, 1985
STREP-KIT
K850765 · JSJ
Culture Kits, Inc.
Microbiology · 58d
Cleared Apr 24, 1985
GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK
K851228 · JTN
Warner-Lambert Co.
Microbiology · 29d
Cleared Apr 24, 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · FRG
American Sterilizer Co.
General Hospital · 21d
Cleared Apr 23, 1985
TF-II HIP PROSTHESIS
K843995 · KWL
Dow Corning Corp. Healthcare...
Orthopedic · 194d
Cleared Apr 23, 1985
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
K850050 · HOZ
Professional Medical Services
Ophthalmic · 105d
Cleared Apr 23, 1985
PROFILE FEMORAL HIP
K850055 · KWA
Depuy, Inc.
Orthopedic · 105d
Cleared Apr 23, 1985
HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
K850572 · HQF
Hgm, Inc.
Ophthalmic · 69d
Cleared Apr 22, 1985
VAN JON SUPER CLYSTER(KIT, ENEMA
K843792 · FCE
Van Jon Co.
Gastroenterology & Urology · 207d
Cleared Apr 22, 1985
EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
K844774 · FCR
Mecron Medical Products, Inc.
Gastroenterology & Urology · 133d
Cleared Apr 22, 1985
MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
K844916 · IYO
Hoffrel Instruments, Inc.
Radiology · 125d