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
104953–104976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1995
IDEAS OCCLUDER
K935964 · DXC
Ideas For Medicine, Inc.
Cardiovascular · 387d
Cleared Jan 04, 1995
IV CATHETER AND OBTURATOR
K941429 · FOS
Becton Dickinson Vascular Access, Inc.
General Hospital · 286d
Cleared Jan 04, 1995
HYDRADJUST IV UROLOGICAL TABLE
K943581 · IXR
Mallinckrodt Group, Inc.
Radiology · 166d
Cleared Jan 04, 1995
A.W.E.L.
K943614 · GCJ
Medi-Flex
General & Plastic Surgery · 161d
Cleared Jan 04, 1995
ANGIOMAT 3000, 6000, CT INJECTOR
K944875 · DXT
Lievel-Flarsheim Co.
Cardiovascular · 93d
Cleared Jan 04, 1995
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · ESW
Cook, Inc.
Gastroenterology & Urology · 71d
Cleared Jan 04, 1995
PHENOBARBITAL CALIBRATORS
K945316 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 64d
Cleared Jan 04, 1995
FOG FREE
K945732 · OCT
Tonn Chemical Co., Inc.
Gastroenterology & Urology · 42d
Cleared Jan 03, 1995
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
K926139 · LJT
Bard Access Systems, Inc.
General Hospital · 757d
Cleared Jan 03, 1995
ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY
K935186 · DQK
Electrophysiology Systems, Inc.
Cardiovascular · 434d
Cleared Jan 03, 1995
LUBRICATING JELLY
K941831 · HIS
Barre-National, Inc.
Obstetrics & Gynecology · 265d
Cleared Jan 03, 1995
ECLIPTOMER
K945604 · KLE
Bisco, Inc.
Dental · 49d
Cleared Jan 03, 1995
SILICONE PUNCTAL PLUG
K945906 · LZU
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Jan 02, 1995
PATIENT EXAMINATION GLOVE
K933602 · LYY
Kerala Rubber & Reclaims, Ltd.
General Hospital · 524d
Cleared Jan 02, 1995
ASEP PLUS SURGICAL DRAPES
K942294 · KKX
Angelica Uniform
General Hospital · 235d
Cleared Jan 02, 1995
OREX SHOE COVERS
K943034 · FXP
Thantex Specialties, Inc.
General Hospital · 189d
Cleared Jan 02, 1995
PATIENT EXAINATION GLOVES
K945045 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 80d
Cleared Jan 02, 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 67d
Cleared Jan 02, 1995
MECHANICAL WHEELCHAIR - SUPERNOVA
K945533 · IOR
Colours 'N Motion
Physical Medicine · 49d
Cleared Jan 02, 1995
MECHANICAL WHEELCHAIR - BOING
K945534 · IOR
Colours 'N Motion
Physical Medicine · 49d
Cleared Dec 30, 1994
IMPACT MODEL 753
K931473 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 646d
Cleared Dec 30, 1994
NEONATAL BREATHING CIRCUIT MODIFICATION
K932288 · CAI
Simplex Medical Systems, Inc.
Anesthesiology · 599d
Cleared Dec 30, 1994
DATEX AS/3 PATIENT MONITOR
K933156 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 549d
Cleared Dec 30, 1994
BARD HYSTERO-FLO II PUMP
K933384 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 536d