FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89665–89688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1998
MACH-SIGMA HANDPIECE, ULTRAPUSH
K980162 · EFB
Nsk Nakanishi, Inc.
Dental · 140d
Cleared Jun 05, 1998
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 05, 1998
LACTOSORB PANELS AND FASTENERS
K980927 · JEY
Biomet, Inc.
Dental · 86d
Cleared Jun 05, 1998
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
K980929 · KGO
Ansell Perry
General Hospital · 85d
Cleared Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Jun 05, 1998
MILLS COLUMELLA PROSTHESIS
K981088 · ETA
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Jun 05, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981133 · LZA
Servicom Services Sdn Bhd
General Hospital · 77d
Cleared Jun 05, 1998
ETEST CIPROFLOXACIN
K981138 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jun 05, 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · KNT
Rusch Intl.
Gastroenterology & Urology · 64d
Cleared Jun 05, 1998
FLARE,FILE, FILL
K981234 · EJB
Lone Star Technologies
Dental · 62d
Cleared Jun 05, 1998
QUANTA LITE RIBOSOME P ELISA
K981237 · MQA
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jun 05, 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · JLW
Bayer Corp.
Chemistry · 56d
Cleared Jun 05, 1998
UNION MEDICAL UM-D30 COAGULATOR
K981430 · GEI
She Medical, Inc.
General & Plastic Surgery · 46d
Cleared Jun 05, 1998
DIO-LIGHT 60 LASER SYSTEM
K981447 · GEX
Nidek, Inc.
General & Plastic Surgery · 44d
Cleared Jun 05, 1998
HYDROPHILIC COATED GUIDEWIRE
K981667 · KNY
Lake Region Mfg., Inc.
Gastroenterology & Urology · 25d
Cleared Jun 05, 1998
RAPIDHCG PREGNANCY TEST
K981770 · JHI
Rapid Diagnostics, Inc.
Chemistry · 17d
Cleared Jun 04, 1998
IAB-04840-U
K970689 · DSP
Arrow Intl., Inc.
Cardiovascular · 464d
Cleared Jun 04, 1998
CES VASCULAR OCCLUSION SYSTEM
K972881 · HCG
Cordis Neurovascular, Inc.
Neurology · 303d
Cleared Jun 04, 1998
3D-MSPECT
K980867 · KPS
Adac Laboratories
Radiology · 90d
Cleared Jun 04, 1998
EMORY CARDIAC TOOL BOX
K980914 · KPS
Emory University
Radiology · 85d
Cleared Jun 04, 1998
VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA...
K980959 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 82d
Cleared Jun 04, 1998
ACCUDEXA BONE DENSITOMETER
K981124 · KGI
Schick Technologies, Inc.
Radiology · 69d
Cleared Jun 04, 1998
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Jun 03, 1998
SMARTLOCK SAFETY SYRINGE
K973888 · MEG
Medical Innovation , Ltd.
General Hospital · 232d