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
75817–75840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714 · GBM
Rusch Intl.
Gastroenterology & Urology · 118d
Cleared Jul 01, 2002
GREAT TOE IMPLANT
K021063 · KWD
Signal Medical Corp.
Orthopedic · 90d
Cleared Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
K021071 · FMF
Biomet, Inc.
General Hospital · 90d
Cleared Jul 01, 2002
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
K021079 · GEI
Conmedcorp
General & Plastic Surgery · 89d
Cleared Jul 01, 2002
MACROPORE OS TRAUMA
K021164 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 81d
Cleared Jul 01, 2002
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
K021165 · IPL
Bromac Assistive Technology
Physical Medicine · 81d
Cleared Jul 01, 2002
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
K021196 · JXG
Neuron Therapeutics, Inc.
Neurology · 76d
Cleared Jul 01, 2002
O&P CRANICAL MOLDING HELMET
K021221 · MVA
Orthotic & Prosthetic Lab, Inc.
Neurology · 75d
Cleared Jul 01, 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · NBC
Biosite Incorporated
Chemistry · 67d
Cleared Jul 01, 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Jul 01, 2002
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
K021825 · KWP
Unitedstates Surgical
Orthopedic · 27d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828 · HWC
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2002
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS...
K021831 · LZU
Lacrimedics, Inc.
Ophthalmic · 27d
Cleared Jul 01, 2002
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
K021869 · GXD
Diros Technology, Inc.
Neurology · 25d
Cleared Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
K021883 · HWC
Mitek Worldwide
Orthopedic · 24d
Cleared Jul 01, 2002
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · GWJ
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Jun 28, 2002
SNORE SAT RECORDER, MODEL SS41
K002159 · MNR
Sagatech Electronics, Inc.
Anesthesiology · 711d
Cleared Jun 28, 2002
BODY FORCE, MODEL BT 6000
K020211 · JOW
Composites Solutions, Inc.
Cardiovascular · 157d
Cleared Jun 28, 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · DRX
Medicotest A/S
Cardiovascular · 143d
Cleared Jun 28, 2002
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K020932 · CAF
Sunrise Medical
Anesthesiology · 98d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 85d
Cleared Jun 28, 2002
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
K021140 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021229 · DDR
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Jun 28, 2002
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE...
K021290 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 66d