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
70009–70032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2003
PARIEFIX
K032093 · GCJ
Sofradim Production
General & Plastic Surgery · 107d
Cleared Oct 22, 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 82d
Cleared Oct 22, 2003
MORALES PROTRACTION FACEMASK
K032392 · DZB
Ortosim, S.A. DE C.V.
Dental · 79d
Cleared Oct 22, 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC...
K032420 · GAM
Ethicon, Inc.
General & Plastic Surgery · 78d
Cleared Oct 22, 2003
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
K032449 · JFB
Migun Medical Instrument Co. , Ltd.
Physical Medicine · 75d
Cleared Oct 22, 2003
GE LOGIQ BOOK
K032477 · IYN
General Electric Co.
Radiology · 71d
Cleared Oct 22, 2003
T2 NAILING SYSTEM
K032523 · HSB
Howmedica Osteonics Corp.
Orthopedic · 68d
Cleared Oct 22, 2003
TARAS THREADED FIXATION PIN
K032532 · JDW
Union Surgical, LLC
Orthopedic · 68d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · HRS
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 22, 2003
CYNOSURE PHOTOGENICA VL
K032565 · GEX
Cynosure, Inc.
General & Plastic Surgery · 63d
Cleared Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · FGE
Ev3, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 22, 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590 · HCG
MicroVention, Inc.
Neurology · 61d
Cleared Oct 22, 2003
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
K032632 · DWF
Estech, Inc.
Cardiovascular · 57d
Cleared Oct 22, 2003
STS SCREW
K032682 · HWC
Ortho-Pro, LLC
Orthopedic · 54d
Cleared Oct 22, 2003
ASCENSION MODULAR RADIAL HEAD
K032686 · KWI
Ascension Orthopedics, Inc.
Orthopedic · 54d
Cleared Oct 22, 2003
CARDICARE MODEL MT-301F & MT-301C
K032714 · FLL
Lumiscope Co., Inc.
General Hospital · 50d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · LPH
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 22, 2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT...
K032929 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 22, 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION...
K032941 · IPF
Rich-Mar Corp.
Physical Medicine · 30d
Cleared Oct 22, 2003
MEDI-HEAT INFANT HEEL WARMER
K032989 · MPO
Mediheat, Inc.
Physical Medicine · 28d
Cleared Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 21, 2003
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · JIL
Analyticon Biotechnologies AG
Chemistry · 334d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · JDQ
Kinamed, Inc.
Orthopedic · 270d