FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74689–74712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2002
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM
K021984 · IYN
Inceptio Medical Technologies, LC
Radiology · 14d
Cleared Jul 02, 2002
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
K022020 · LQY
Toei Electric Co., Ltd.
Dental · 12d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Synthes (Usa)
Orthopedic · 452d
Cleared Jul 01, 2002
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
K011220 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 437d
Cleared Jul 01, 2002
BIOTOUCH MASSAGE THERAPY SYSTEM
K013061 · IRP
Tactile Systems Technology, Inc.
Physical Medicine · 293d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
Cook, Inc.
General Hospital · 280d
Cleared Jul 01, 2002
CARESIDE GGT
K020486 · JPZ
Careside, Inc.
Chemistry · 138d
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