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
100657–100680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1995
EBICE
K953532 · ILO
Electro-Biology, Inc.
Physical Medicine · 69d
Cleared Oct 04, 1995
IMPERVA FLUOROBOND
K953612 · KLE
Shofu Dental Corp.
Dental · 63d
Cleared Oct 04, 1995
IMPERVA ENSURABOND
K953613 · KLE
Shofu Dental Corp.
Dental · 63d
Cleared Oct 03, 1995
SIEMENS SONOLINE 4XX
K946179 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 288d
Cleared Oct 03, 1995
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821 · DSI
Hewlett-Packard Co.
Cardiovascular · 222d
Cleared Oct 03, 1995
DORNIER THERMAFOCUS 360 FIBER
K950996 · GEX
Daimler-Benz Aerospace
General & Plastic Surgery · 214d
Cleared Oct 03, 1995
MINISTRIP HCG
K951705 · JHI
International Newtech Development, Inc.
Chemistry · 172d
Cleared Oct 03, 1995
LMT 20 HH LASER SURGIVAL SYSTEM
K952045 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 155d
Cleared Oct 03, 1995
LMT 20 AA LASER SURGICAL SYSTEM
K952046 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 155d
Cleared Oct 03, 1995
LMT 40 AA LASER SURGICAL SYSTEM
K952047 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 155d
Cleared Oct 03, 1995
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 144d
Cleared Oct 03, 1995
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
K952437 · CFR
Data Medical Associates, Inc.
Chemistry · 131d
Cleared Oct 03, 1995
ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE
K952553 · FMF
Alpha Medica
General Hospital · 124d
Cleared Oct 03, 1995
CALVITRON HAIR TRANSPLANT SYSTEM
K952737 · GAH
Medicamat S.A.
General & Plastic Surgery · 110d
Cleared Oct 03, 1995
SHROUDED PLASTIC CANNULA
K952834 · FMI
Medical Associates Network, Inc.
General Hospital · 105d
Cleared Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · GWG
United States Surgical, A Division of...
Neurology · 88d
Cleared Oct 03, 1995
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K953416 · MNH
Arcan Orthopaedic Corp.
Orthopedic · 85d
Cleared Oct 03, 1995
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · DZE
Nobelpharma USA, Inc.
Dental · 74d
Cleared Oct 03, 1995
MICROPRIME
K953504 · KLE
Danville Engineering, Inc.
Dental · 69d
Cleared Oct 03, 1995
FIRST RESPONSE OVULATION PREDICTOR TEST
K953581 · CEP
Armkel, LLC
Chemistry · 63d
Cleared Oct 03, 1995
ABBOTT IMX PROLACTIN(MODIFICATION)
K953656 · CFT
Abbott Mfg., Inc.
Chemistry · 77d
Cleared Oct 03, 1995
KENSORB
K953830 · GDY
Kentron Health Care, Inc.
General & Plastic Surgery · 48d
Cleared Oct 03, 1995
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · JIX
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Oct 03, 1995
SPECTACLE SUN GLASSES (NON PRESCRIPTION)
K954173 · HQY
Monte Carlo Eyewear, Inc.
Ophthalmic · 28d