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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38785–38808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 26, 2013
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K133283 · GEX
Candela Corp.
General & Plastic Surgery · 62d
Cleared Dec 26, 2013
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
K133422 · MOS
Neocoil, LLC
Radiology · 48d
Cleared Dec 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS...
K123763 · CIB
Immunodiagnostic Systems , Ltd.
Chemistry · 382d
Cleared Dec 24, 2013
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 319d
Cleared Dec 24, 2013
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
K130519 · FTC
Philips Lighting Company
General & Plastic Surgery · 300d
Cleared Dec 24, 2013
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
K130572 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 295d
Cleared Dec 24, 2013
SWABCAP AND SWABFLUSH
K130975 · QBP
Excelsior Medical Corp.
General & Plastic Surgery · 260d
Cleared Dec 24, 2013
SIGNIFY BIOACTIVE
K130977 · MQV
Globus Medical, Inc.
Orthopedic · 259d
Cleared Dec 24, 2013
ACUSON
K131164 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 244d
Cleared Dec 24, 2013
MOZEC - RX PTCA BALLOON DILATATION CATHETER
K131169 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 244d
Cleared Dec 24, 2013
INTUITION - TDA, TVA, PARAMETRIC MAPPING
K131447 · LLZ
Terarecon,Inc.
Radiology · 218d
Cleared Dec 24, 2013
VELOX ANTERIOR CERVICAL PLATE SYSTEM
K131521 · KWQ
Spinecraft, LLC
Orthopedic · 210d
Cleared Dec 24, 2013
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · MQP
Pioneer Surgical Technology, Inc.
Orthopedic · 195d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Dec 24, 2013
COROENT STERILE IMPLANTS SYSTEM
K132601 · MAX
Nu Vasive, Incorporated
Orthopedic · 126d
Cleared Dec 24, 2013
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787 · HRS
Aap Implantate AG
Orthopedic · 109d
Cleared Dec 24, 2013
VENUE 50
K133431 · IYN
Ge Healthcare
Radiology · 46d
Cleared Dec 23, 2013
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
K122932 · JOH
Fogless International AB
Anesthesiology · 455d
Cleared Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · HRN
Keeler, Ltd.
Ophthalmic · 188d
Cleared Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID
Phadia US, Inc.
Immunology · 186d
Cleared Dec 23, 2013
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
K131901 · BZD
3B Medical, Inc.
Anesthesiology · 181d
Cleared Dec 23, 2013
ASCOT
K132310 · KWQ
Backroads Consulting, Inc.
Orthopedic · 151d
Cleared Dec 23, 2013
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · FYA
Zimmer, Inc.
General Hospital · 144d
Cleared Dec 23, 2013
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER...
K132500 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 136d