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
72145–72168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 13, 2003
MICROFIX QUICKANCHOR PLUS
K024115 · HWC
Mitek Worldwide
Orthopedic · 90d
Cleared Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
K030350 · KYF
Optonol, Ltd.
Ophthalmic · 38d
Cleared Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K030455 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Mar 13, 2003
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES...
K030566 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Mar 12, 2003
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
K022004 · DQO
Biosensors International-USA
Cardiovascular · 266d
Cleared Mar 12, 2003
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693 · FRF
Airex, Inc.
General Hospital · 131d
Cleared Mar 12, 2003
OPTIMA, SPINAL SYSTEM
K024096 · MNI
U&I Corp., America
Orthopedic · 90d
Cleared Mar 12, 2003
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
K024138 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Mar 12, 2003
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K024201 · HAW
Image-Guided Neurologics, Inc.
Neurology · 82d