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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143473–143496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1986
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · BXN
Puritan Bennett Corp.
Anesthesiology · 15d
Cleared Jun 19, 1986
QUALI-MED'S OPERATING ROOM DRAPES
K862172 · KKX
Quali-Med, Inc.
General Hospital · 10d
Cleared Jun 19, 1986
RMP COMPANT CRICOTHYROTOMY EQUIPMENT STORAGE TRAY
K862197
Rmp Co.
General & Plastic Surgery · 10d
Cleared Jun 18, 1986
SKYLARK MODEL 1001 TENS DEVICE
K853898 · GZJ
Peleg Intl. Co.
Neurology · 271d
Cleared Jun 18, 1986
ENDO-LASE CD40 FOR NEUROSURGERY
K853900 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 271d
Cleared Jun 18, 1986
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · FRC
Parke-Davis Co.
General Hospital · 177d
Cleared Jun 18, 1986
BIOFEEDBACK MICROLAB
K860271 · HCC
Hrm Software/Div. of Human Relations...
Neurology · 142d
Cleared Jun 18, 1986
VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE
K860826 · DWL
Bauerfeind GmbH & Co.
General Hospital · 106d
Cleared Jun 18, 1986
NUTRI-CATH - FEEDING TUBE
K861090 · KNT
Gesco Intl., Inc.
Gastroenterology & Urology · 86d
Cleared Jun 18, 1986
ANTHRON CATHETERS & SETS
K861117 · FOZ
Toray Industries (America), Inc.
General Hospital · 85d
Cleared Jun 18, 1986
SKYLARK GB 1000
K861214 · GZJ
Peleg Intl. Co.
Neurology · 79d
Cleared Jun 18, 1986
IMPAX, MALE IMPOTENCE AID
K861468 · LKY
Lehigh Group
Gastroenterology & Urology · 58d
Cleared Jun 18, 1986
ENGSTROM ERICA II RESPIRATOR
K862025 · CBK
Gambro, Inc.
Anesthesiology · 21d
Cleared Jun 18, 1986
COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
K862220 · HAW
Stereotactic Medical Systems, Inc.
Neurology · 7d
Cleared Jun 18, 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · BTO
Bivona Medical Technologies
Anesthesiology · 5d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696 · LFX
Labsystems, Inc.
Microbiology · 285d
Cleared Jun 17, 1986
NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281
K860314 · IPF
Neurotech, Inc.
Physical Medicine · 140d
Cleared Jun 17, 1986
NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280
K860315 · IPF
Neurotech, Inc.
Physical Medicine · 140d
Cleared Jun 17, 1986
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · KLS
Abbott Laboratories
Toxicology · 131d
Cleared Jun 17, 1986
DISPOSABLE FLUSH DEVICE
K860681 · DRS
Hewlett-Packard Co.
Cardiovascular · 112d
Cleared Jun 17, 1986
THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
K860704 · NZA
Keymed, Inc.
General Hospital · 111d
Cleared Jun 17, 1986
GOTTEX SUNGLASSES
K861021 · HQG
Private Eyes Sunglass Corp.
Ophthalmic · 91d
Cleared Jun 17, 1986
MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL
K861047 · LNK
Sharplan Industries, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 17, 1986
POWERSTIM ELECTRONIC MUSCLE STIMULATOR
K861399
Bio-Med Systems Corp.
Physical Medicine · 63d