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
89161–89184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 03, 1998
CT SCOPE
K974344 · JAK
Elscint, Inc.
Radiology · 196d
Cleared Jun 03, 1998
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 196d
Cleared Jun 03, 1998
SHELHIGH NO-REACT PERICARDIAL PATCHES
K974914 · DXZ
Shelhigh, Inc.
Cardiovascular · 177d
Cleared Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850 · DSP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jun 03, 1998
JPACS
K980918 · LMD
Philips Medical Systems (Cleveland),...
Radiology · 84d
Cleared Jun 03, 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 29d
Cleared Jun 03, 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND...
K981687 · JXM
Phamatech
Toxicology · 21d
Cleared Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722 · LCX
Quidel Corp.
Chemistry · 19d
Cleared Jun 02, 1998
CS/3(TM) MONITORS*
K974792 · DSI
Datex-Engstrom, Inc.
Cardiovascular · 162d