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
70513–70536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139 · IYN
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
RAPHAEL
K022679 · CBK
Hamilton Medical AG
Anesthesiology · 436d
Cleared Oct 22, 2003
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
K023139 · KGO
Van Oostveen Medical B.V.
General Hospital · 397d
Cleared Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 181d
Cleared Oct 22, 2003
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE...
K031329 · IMI
Dynatronics Corp.
Physical Medicine · 177d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · MNI
Signus Medical, LLC
Orthopedic · 168d
Cleared Oct 22, 2003
INTER-OS LIMB LENGTHENER
K031875 · KTT
Inter-Os Technologies
Orthopedic · 127d
Cleared Oct 22, 2003
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
K031953 · NOP
Focus Technologies, Inc.
Microbiology · 119d
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