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

Filters: Cleared only ×
176,076 results
74425–74448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
K021060 · FKP
Fresenius Medical Care North America
Gastroenterology & Urology · 225d
Cleared Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 183d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 107d
Cleared Nov 13, 2002
PHYSICAL MONITORING REGISTRATION UNIT
K022719 · IKN
Maryrose Cusimano, Ph.D./Phil Reaston
Neurology · 90d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768 · MNI
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769 · JJX
Bionostics, Inc.
Chemistry · 84d
Cleared Nov 13, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 83d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Synthes (Usa)
Orthopedic · 83d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 13, 2002
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · MQX
Mandala Health Care, LLC
General Hospital · 61d
Cleared Nov 13, 2002
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND...
K023153 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 51d
Cleared Nov 13, 2002
ORS-3000LD
K023282 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
1075LD HUSH-SLUSH
K023283 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
QUANTIX/ND DEVICE
K023431 · DPW
Cardiosonix, Ltd.
Cardiovascular · 29d
Cleared Nov 13, 2002
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
K023433 · MID
Pharmacia Diagnostics GmbH & Co. KG
Immunology · 29d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
K023492 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 13, 2002
PK ZIP WING CUTTING DISSECTOR
K023493 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · KWP
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cook, Inc.
Cardiovascular · 26d
Cleared Nov 13, 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 21d