Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
57025–57048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
K080610 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Mar 31, 2008
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
K080698 · NEU
Senorx, Inc.
General & Plastic Surgery · 19d
Cleared Mar 28, 2008
HOMECHECK MULTIPLE DRUG CUP TEST
K071489 · DKZ
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 303d
Cleared Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
K072847 · KGI
Hologic, Inc.
Radiology · 176d
Cleared Mar 28, 2008
SPINOUS PROCESS PLATE SYSTEM
K073278 · KWP
Nuvasive, Inc.
Orthopedic · 128d
Cleared Mar 28, 2008
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
K073519 · QEZ
Kensey Nash Corp.
Cardiovascular · 105d
Cleared Mar 28, 2008
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
K073550 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Mar 28, 2008
SOYALA FULL FACE MASK GEL VENTED
K073673 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 92d
Cleared Mar 28, 2008
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K073713 · DZE
Blue Sky Bio, LLC
Dental · 88d
Cleared Mar 28, 2008
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL...
K080402 · KWS
Encore Medical, L.P.
Orthopedic · 43d
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · OLW
Ge Healthcare
Neurology · 631d
Cleared Mar 27, 2008
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
K072185 · FRF
Airistar Technologies, LLC
General Hospital · 234d
Cleared Mar 27, 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
K072400 · LZA
Sgmp Co., Ltd.
General Hospital · 213d
Cleared Mar 27, 2008
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND...
K072403 · LYY
Sgmp Co., Ltd.
General Hospital · 213d
Cleared Mar 27, 2008
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
K072730 · NHA
Dentsply Intl.
Dental · 183d
Cleared Mar 27, 2008
PORTRAIT PSR, MODEL 745915
K073111 · GEI
Rhytec Incorporated
General & Plastic Surgery · 143d
Cleared Mar 27, 2008
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
K080228 · LBH
Novamin Technology, Inc.
Dental · 57d
Cleared Mar 27, 2008
HD7 DIAGNOSTIC ULTRASOUND SYSTEM
K080548 · IYN
Phillips Medical Systems
Radiology · 28d
Cleared Mar 27, 2008
HABIB HEXABLATE 10
K080717 · GEI
Emcision , Ltd.
General & Plastic Surgery · 14d
Cleared Mar 27, 2008
AVS PL PEEK SPACERS, MODELS 48351 AND 48353
K080758 · MAX
Stryker Corp.
Orthopedic · 9d
Cleared Mar 26, 2008
VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
K063813 · CCK
Ventlab Corp.
Anesthesiology · 460d
Cleared Mar 26, 2008
BELLA
K073262 · IZH
Beekley Corp.
Radiology · 127d
Cleared Mar 26, 2008
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
K073342 · DZL
Salvin Dental Specialties, Inc.
Dental · 119d
Cleared Mar 26, 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
K073583 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 97d