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
107377–107400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1994
MED-EVAC-4 MEDICAL EVACUATION STRETCHER
K942356 · FPP
Montery Bay Corp.
General Hospital · 63d
Cleared Jul 19, 1994
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
K942526 · MKY
Life Medical Sciences, Inc.
General & Plastic Surgery · 53d
Cleared Jul 19, 1994
LORREX POST OPERATIVE SPONGES
K942691 · EFQ
Lorons International Corp.
General & Plastic Surgery · 42d
Cleared Jul 19, 1994
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
K942879 · GCJ
Deroyal Industries, Inc.
General & Plastic Surgery · 32d
Cleared Jul 19, 1994
SIMPULSE SOLO SUCTION IRRIGATOR
K942886 · FQH
Davol Inc., Sub. C. R. Bard, Inc.
General Hospital · 32d
Cleared Jul 19, 1994
CLAMPS AND CLIPS
K942896 · MDM
Surgin Surgical Instrumentation, Inc.
General & Plastic Surgery · 29d
Cleared Jul 19, 1994
O-R-EZ TIP CLEANER
K942957 · GEI
O-R-Ez, Inc.
General & Plastic Surgery · 26d
Cleared Jul 18, 1994
NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
K931651 · JWH
Intermedics Orthopedics
Orthopedic · 469d
Cleared Jul 18, 1994
EUTRA GEL FOR WOUND DRESSING
K932291 · MGQ
Swiss American Products, Inc.
General & Plastic Surgery · 434d
Cleared Jul 18, 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482 · GTZ
Medix Biotech, Inc.
Microbiology · 420d
Cleared Jul 18, 1994
UNI-FRAME HEAD IMMOBILIZATION SYSTEM
K933227 · IYE
Medtec, Inc.
Radiology · 381d
Cleared Jul 18, 1994
XOMED-TREACE SCOPESHEATH
K933672 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 355d
Cleared Jul 18, 1994
QUICKVUE IN-LINE ONE-STEP STREP A TEST
K934484 · GTZ
Quidel Corp.
Microbiology · 307d
Cleared Jul 18, 1994
VAC-LOK IMMOBILIZATION SYSTEM
K935300 · IYE
Medtec, Inc.
Radiology · 258d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-250
K935411 · IYE
Medtec, Inc.
Radiology · 251d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-200
K935412 · IYE
Medtec, Inc.
Radiology · 251d
Cleared Jul 18, 1994
KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
K935951 · JDI
Kirschner Medical Corp.
Orthopedic · 217d
Cleared Jul 18, 1994
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
K936010 · DDC
Biomerica, Inc.
Immunology · 214d
Cleared Jul 18, 1994
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
K936282 · DQO
Cordis Neurovascular, Inc.
Cardiovascular · 200d
Cleared Jul 18, 1994
ABBOTT PRISM ANALYZER
K940289 · JJE
Abbott Mfg., Inc.
Chemistry · 138d
Cleared Jul 18, 1994
OPHTHALMIC CRYO UNIT
K940373 · HPS
Dutch Ophthalmic USA, Inc.
Ophthalmic · 173d
Cleared Jul 18, 1994
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K940416 · GZB
Medtronic Vascular
Neurology · 171d
Cleared Jul 18, 1994
VELO ACE
K940540 · IXW
Emix U.S.A., Inc.
Radiology · 161d
Cleared Jul 18, 1994
TEC 2101 (MODEL MT-HPLGD)
K941169 · IWE
Medtec, Inc.
Radiology · 126d