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
89545–89568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1998
KLEENASEPTIC
K981023 · LRJ
Metrex Research Corp.
General Hospital · 42d
Cleared Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...
K981280 · IXW
Bayer Corp., Agfa Div.
Radiology · 22d
Cleared Apr 29, 1998
CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
K974674 · GEX
Cynosure, Inc.
General & Plastic Surgery · 135d
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Apr 29, 1998
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K980373 · HCC
Ultramind International , Ltd.
Neurology · 89d
Cleared Apr 29, 1998
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980491 · MBI
Innovasive Devices, Inc.
Orthopedic · 79d
Cleared Apr 29, 1998
THE NUFFIELD TOTAL KNEE SYSTEM
K980545 · JWH
Corin USA
Orthopedic · 76d
Cleared Apr 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · HWC
Innovasive Devices, Inc.
Orthopedic · 68d
Cleared Apr 29, 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774 · LZO
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 29, 1998
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
K980776 · JXM
Tcpi, Inc.
Toxicology · 58d
Cleared Apr 29, 1998
SURETOUCH
K980784 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 1998
DUMEX PAK-ITS WOVEN RIBBON PACKING
K980791 · EFQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 58d
Cleared Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · JLW
Abbott Laboratories
Chemistry · 37d
Cleared Apr 29, 1998
BRIGHTSTAR
K981081 · FSY
Hill-Rom, Inc.
General & Plastic Surgery · 36d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274 · MNH
Acromed Corp.
Orthopedic · 21d
Cleared Apr 28, 1998
BABYPAC
K970158 · CBK
Pneupac, Inc.
Anesthesiology · 467d
Cleared Apr 28, 1998
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · DPS
Ates Medical S.R.L.
Cardiovascular · 259d
Cleared Apr 28, 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · IPF
Universal Technology Systems, Inc.
Physical Medicine · 90d
Cleared Apr 28, 1998
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
K980350 · GCJ
Cuda Products Co.
General & Plastic Surgery · 90d
Cleared Apr 28, 1998
I.V. CATHETER SYSTEM
K980493 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 78d