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
88393–88416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1998
GYNEX EXTENDED REACH NEEDLE
K980238 · HEE
Gynex Corp.
Obstetrics & Gynecology · 210d
Cleared Aug 21, 1998
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
K980885 · GGP
Shield Diagnostics, Ltd.
Hematology · 165d
Cleared Aug 21, 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · HDB
Hollister, Inc.
Obstetrics & Gynecology · 158d
Cleared Aug 21, 1998
ULTRA IMAGE AND ULTRA SCAN
K981028 · ITX
Sonotech, Inc.
Radiology · 155d
Cleared Aug 21, 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · LSE
Zeus Scientific, Inc.
Microbiology · 147d
Cleared Aug 21, 1998
BIPOLAR FEMORAL HEAD
K981238 · KWY
Whiteside Biomechanics, Inc.
Orthopedic · 140d
Cleared Aug 21, 1998
ARGOMEDICAL BIPOLAR SYSTEM
K981451 · KWL
Stelkast Company
Orthopedic · 121d
Cleared Aug 21, 1998
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · LGD
Diamedix Corp.
Microbiology · 116d
Cleared Aug 21, 1998
MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
K981568 · GKZ
Cdc Technologies, Inc.
Hematology · 112d
Cleared Aug 21, 1998
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K981993 · ODA
The Olympus Optical Co.
Radiology · 74d
Cleared Aug 21, 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · LLZ
Visualization Technology, Inc.
Radiology · 74d
Cleared Aug 21, 1998
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG...
K982238 · MJH
Binax, Inc.
Microbiology · 57d
Cleared Aug 21, 1998
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · IOR
Invacare Corp.
Physical Medicine · 46d
Cleared Aug 21, 1998
VES 1501-M
K982409 · FWF
Angiolaz, Inc.
General & Plastic Surgery · 42d
Cleared Aug 21, 1998
MEDWORKS INSEMINATION CATHETER
K982628 · MFD
Medworks Corp.
Obstetrics & Gynecology · 24d
Cleared Aug 21, 1998
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S...
K982638 · QSY
Innovative Technologies , Ltd.
General & Plastic Surgery · 23d
Cleared Aug 21, 1998
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1,...
K982845 · JJT
More Diagnostics
Chemistry · 9d
Cleared Aug 20, 1998
PTA BALLOON CATHETER
K980390 · LIT
Cook, Inc.
Cardiovascular · 199d
Cleared Aug 20, 1998
NPB3900 SERIES PATIENT MONITORS
K980411 · MHX
Analogic Corp.
Cardiovascular · 198d
Cleared Aug 20, 1998
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
K980619 · MHX
Sabratek Corp.
Cardiovascular · 183d
Cleared Aug 20, 1998
PLAQ-ATAQ-I
K980995 · EFW
Ethicare
Dental · 174d
Cleared Aug 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · HRX
Linvatec Corp.
Orthopedic · 104d
Cleared Aug 20, 1998
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K981747 · DRS
Sunscope Intl., Inc.
Cardiovascular · 94d
Cleared Aug 20, 1998
VISAGE COSMETIC SURGERY SYSTEM
K981870 · GEI
Arthrocare Corp.
General & Plastic Surgery · 84d