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
72649–72672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2003
FENESTRATED INFUSION CATHETER
K024190 · FRN
Promedic, Inc.
General Hospital · 88d
Cleared Mar 17, 2003
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
K024235 · DQA
Dolphin Medical, Inc.
Anesthesiology · 84d
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 77d
Cleared Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · MQP
Synthes (Usa)
Orthopedic · 76d
Cleared Mar 17, 2003
SUPERBOND
K030161 · EJH
American Dent-All, Inc.
Dental · 60d
Cleared Mar 17, 2003
SUTURTEK FASTCLOSE SUTURING DEVICE
K030227 · GAL
Suturtek Incorporated
General & Plastic Surgery · 54d
Cleared Mar 17, 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 17, 2003
MODULEAF
K030609 · IXI
Mrc Systems GmbH
Radiology · 19d
Cleared Mar 17, 2003
SAS RSV CONTROL KIT
K030628 · JJX
Sa Scientific, Inc.
Chemistry · 18d
Cleared Mar 14, 2003
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
K024124 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 14, 2003
ORAMAGICRX ORAL WOUND RINSE
K024180 · OLR
Mpm Medical., Inc.
General & Plastic Surgery · 86d
Cleared Mar 14, 2003
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP,...
K024199 · FTL
Osteobiologics, Inc.
General & Plastic Surgery · 84d
Cleared Mar 14, 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 81d
Cleared Mar 14, 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · DTL
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared Mar 14, 2003
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
K030228 · KGO
Pt. Medisafe Technologies
General Hospital · 51d
Cleared Mar 14, 2003
GEM, MODEL 004110
K030464 · BZG
Collins Medical, Inc.
Anesthesiology · 30d
Cleared Mar 14, 2003
GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
K030467 · FPA
Iv Medical, Inc.
General Hospital · 30d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · HCG
Boston Scientific, Target
Neurology · 29d
Cleared Mar 14, 2003
CPCA2000 COUNTERPULSATION SYSTEM
K030532 · DRN
Cpca2000, Inc.
Cardiovascular · 23d
Cleared Mar 14, 2003
MAS LIPID LEVEL 1 AND 2
K030679 · JJY
Medical Analysis Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 2003
CANDELA GENTLE YAG LASER SYSTEM
K022923 · GEX
Candela Corp.
General & Plastic Surgery · 190d
Cleared Mar 13, 2003
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
K023105 · CIC
Elan Diagnostics
Chemistry · 176d
Cleared Mar 13, 2003
GYRUS PLASMA SKIN RESURFACING SYSTEM
K023111 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 175d