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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40921–40944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON
Becton, Dickinson & CO
Microbiology · 234d
Cleared Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K130094 · NBW
Abbott Diabetes Care
Chemistry · 168d
Cleared Jun 27, 2013
AXLE INTERSPINOUS FUSION SYSTEM
K130438 · PEK
X-Spine Systems, Inc.
Orthopedic · 126d
Cleared CT Jun 27, 2013
LYRIC2
K130790 · ESD
Phonak, LLC
Ear, Nose, Throat · 97d
Cleared Jun 27, 2013
STREAMLINE TL SPINAL SYSTEM
K131100 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 69d
Cleared Jun 27, 2013
EARPROBE
K131141 · GWJ
Path Medical GmbH
Neurology · 65d
Cleared Jun 27, 2013
KEELER SLIT LAMP H-SERIES
K131589 · HJO
Keeler, Ltd.
Ophthalmic · 27d
Cleared Jun 27, 2013
STARCHMARK BREAST TISSUE MARKER
K131654 · NEU
Senorx, Inc.
General & Plastic Surgery · 21d
Cleared Jun 27, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K131683 · MBI
Depuy Mitek, Inc., A Johnson and...
Orthopedic · 17d
Cleared Jun 26, 2013
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · KNT
Kimberly Clark Corporation
Gastroenterology & Urology · 299d
Cleared Jun 26, 2013
KSEA BIPOLAR ELECTRODE
K122983 · HIN
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 273d
Cleared Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 272d
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Becton, Dickinson and Company
Microbiology · 250d
Cleared Jun 26, 2013
HEMOCONCENTRATOR
K123288 · KDI
Maquet Cardiopulmonary, AG
Gastroenterology & Urology · 247d
Cleared Jun 26, 2013
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
K130549 · JAD
Carl Zeiss Meditec, Inc.
Radiology · 114d
Cleared Jun 26, 2013
MONITOR B40
K130584 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 113d
Cleared Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · JIT
Diazyme Laboratories
Chemistry · 28d
Cleared Jun 25, 2013
INFINI RADIOFREQUENCY SYSTEM
K121481 · GEI
Lutronic Corporation
General & Plastic Surgery · 403d
Cleared Jun 25, 2013
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
K121628 · DXH
Epi Mobile Health Solutions (S) Pte,...
Cardiovascular · 386d
Cleared Jun 25, 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON...
K122503 · NDN
Neuro Therm, Inc.
Orthopedic · 313d
Cleared Jun 25, 2013
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0...
K130008 · HRS
I.T.S. GmbH
Orthopedic · 174d
Cleared Jun 25, 2013
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
K130487 · FMI
Pyng Medical Corp.
General Hospital · 120d
Cleared Jun 25, 2013
PRIMI AND SECONDI SUPPORT CATHETERS
K130850 · DQY
Thermopeutix, Inc.
Cardiovascular · 90d
Cleared Jun 25, 2013
EBA2 FEMORAL NAILING SYSTEM
K131005 · HSB
Citieffe S.R.L.
Orthopedic · 75d