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
88849–88872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1998
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING...
K981180 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 149d
Cleared Aug 28, 1998
AMY
K981653 · JFJ
Abbott Laboratories
Chemistry · 109d
Cleared Aug 28, 1998
LIGASURE VESSEL SEALING SYSTEM
K981916 · GEI
Valleylab, Inc.
General & Plastic Surgery · 88d
Cleared Aug 28, 1998
ACCU-CHECK VOICEMATE
K982079 · LFR
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Aug 28, 1998
CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL...
K982740 · DYB
Cordis Webster, Inc.
Cardiovascular · 22d
Cleared Aug 28, 1998
MODIFICATION TO EBI SPINELINK SYSTEM
K982908 · KWP
Electro-Biology, Inc.
Orthopedic · 10d
Cleared Aug 27, 1998
CAOW HEMOSTASIS SYSTEM
K972689 · DXC
Anlam Corp.
Cardiovascular · 406d
Cleared Aug 27, 1998
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS...
K973943 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 315d
Cleared Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090 · MSE
Fresenius Medical Care North America
Gastroenterology & Urology · 302d
Cleared Aug 27, 1998
WHISTLE WATCH
K980550 · BZH
Harwill Medical (Pty) , Ltd.
Anesthesiology · 196d
Cleared Aug 27, 1998
IMAGE POST-PROCESSING TECHNIQUES
K980831 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 176d
Cleared Aug 27, 1998
SLT BIPOLAR SHEATH
K981041 · ERL
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 160d
Cleared Aug 27, 1998
IL TEST PLASMIN INHIBITOR
K981696 · GGP
Instrumentation Laboratory CO
Hematology · 105d
Cleared Aug 27, 1998
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
K981705 · DKZ
American Bio Medica Corp.
Toxicology · 105d
Cleared Aug 27, 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
K982366 · MVM
Inova Diagnostics, Inc.
Immunology · 51d
Cleared Aug 27, 1998
ENDO-SCRUB/ENDO-SCRUB 2
K982594 · EOB
Xomed, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 26, 1998
AU5 ULTRASOUND IMAGING SYSTEM
K980468 · IYN
Biosound Esaote, Inc.
Radiology · 201d
Cleared Aug 26, 1998
FETH-R-KATH
K981329 · BSO
Epimed International, Inc.
Anesthesiology · 135d
Cleared Aug 26, 1998
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE...
K981897 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Aug 26, 1998
AQUILION CT SCANNER, MODEL TSX-101A
K982265 · JAK
Toshiba America Medical Systems, In.C
Radiology · 58d
Cleared Aug 26, 1998
HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER,...
K982378 · KPO
Solution Technologies
Gastroenterology & Urology · 49d
Cleared Aug 26, 1998
EC6 PLETHYSMOGRAPH
K982707 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 23d
Cleared Aug 25, 1998
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD...
K973593 · FRN
Bridge Medical, Inc.
General Hospital · 337d
Cleared Aug 25, 1998
MICROVIT MT-100
K973735 · DSH
Schiller America, Inc.
Cardiovascular · 329d