FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
99073–99096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · KWS
Osteonics Corp.
Orthopedic · 133d
Cleared Apr 09, 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · DWS
GE Medical Systems
Cardiovascular · 84d
Cleared Apr 09, 1996
CONMED EKG STRIPPER
K960264 · DRX
Conmedcorp
Cardiovascular · 82d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · LTT
Accumed Intl., Inc.
Microbiology · 75d
Cleared Apr 09, 1996
K-WIRE
K960482 · HTY
American Medical Specialties, Inc.
Orthopedic · 67d
Cleared Apr 09, 1996
STEINMAN PIN
K960483 · HTY
American Medical Specialties, Inc.
Orthopedic · 67d
Cleared Apr 09, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · LIT
Boston Scientific Corp
Cardiovascular · 67d
Cleared Apr 09, 1996
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K960517 · LIT
C.R. Bard, Inc.
Cardiovascular · 64d
Cleared Apr 08, 1996
PINNACLE3 APEX
K951581 · IYE
Adac Laboratories
Radiology · 370d
Cleared Apr 08, 1996
LAST IMAGE HOLD
K951942 · LMB
Insight Systems
Radiology · 348d
Cleared Apr 08, 1996
DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
K953530 · IYO
Biosound, Inc.
Radiology · 256d
Cleared Apr 08, 1996
FIRST PICC INTRODUCER CATHETER
K954906 · DYB
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 166d
Cleared Apr 08, 1996
ACCELERATED TRANSMISSION PROTOCOL
K955060 · DXH
Instromedix, Inc.
Cardiovascular · 158d
Cleared Apr 08, 1996
HP SONOS 100CF ULTRASOUND IMAGING SYSTEM
K955327 · IYN
Hewlett-Packard Co.
Radiology · 140d
Cleared Apr 08, 1996
COFIED MODULAR SHOULDER SYSTEM
K955767 · KWS
Smith & Nephew Richards, Inc.
Orthopedic · 109d
Cleared Apr 08, 1996
CARBON DIOXIDE - DST
K960035 · KHS
Trace America, Inc.
Chemistry · 96d
Cleared Apr 08, 1996
INSTATRAK
K960330 · LLZ
Visualization Technology, Inc.
Radiology · 75d
Cleared Apr 07, 1996
RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000
K955144 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 146d
Cleared Apr 07, 1996
PHILIPS SITE VIEW WORKSTATION
K960809 · LMD
Philips Medical Systems North...
Radiology · 39d
Cleared Apr 05, 1996
MRI'S ALL SILICONE FOLEY CATHETER
K944676 · EZL
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 561d
Cleared Apr 05, 1996
SIEMENS Q64XXX
K950157 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 444d
Cleared Apr 05, 1996
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
K953971 · CDT
Trace America, Inc.
Chemistry · 226d
Cleared Apr 05, 1996
IMPLEX CERAMIC HEAD
K955117 · LZO
Implex Corp.
Orthopedic · 148d
Cleared Apr 05, 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 144d