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
88345–88368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 25, 1998
MT-200
K973751 · DQK
Schiller America, Inc.
Cardiovascular · 328d
Cleared Aug 25, 1998
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K974220 · DPS
Micromedical, Inc.
Cardiovascular · 286d
Cleared Aug 25, 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742 · HNO
Moria, Inc.
Ophthalmic · 99d
Cleared Aug 25, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K981801 · LFH
Princeton BioMeditech Corp.
Toxicology · 96d
Cleared Aug 25, 1998
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS...
K981931 · CGN
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 84d
Cleared Aug 25, 1998
THE WAVE DIGITAL PHACO SYSTEM
K981989 · HQC
Circuit Tree
Ophthalmic · 81d
Cleared Aug 25, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
K982061 · DIO
OraSure Technologies, Inc.
Toxicology · 82d
Cleared Aug 25, 1998
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
K982429 · PSZ
Zymetx, Inc.
Microbiology · 43d
Cleared Aug 25, 1998
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
K982442 · IZD
Care Wise Medical Products Corp.
Radiology · 42d