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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147577–147600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM - POWDERED FORM
K852603
Mediatech, Inc.
Pathology · 23d
Cleared Jul 12, 1985
X-AMYLASE ASSAY KIT
K852636 · CIJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Jul 11, 1985
KENZ 80Z MARK II
K843731 · DSI
Suzuken Co., Ltd.
Cardiovascular · 290d
Cleared Jul 11, 1985
THE WHITE RIVER PORTA-ELEC-BREAST PUMP
K850705 · HGX
Natural Technologies, Inc.
Obstetrics & Gynecology · 140d
Cleared Jul 11, 1985
CONCEPT DEFRERE ELECTRODE
K851040 · GEI
Concept, Inc.
General & Plastic Surgery · 119d
Cleared Jul 11, 1985
CARDIAC COOLING JACKET
K851077 · KRI
Pat O. Daily
Cardiovascular · 115d
Cleared Jul 11, 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · DTD
Intermedics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · DTD
Intermedics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · DTB
Telectronics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
NAMAN POTTS COURNAND NEEDLE
K851832 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN SELDINGER NEEDLE
K851833 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR
K852018
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 64d
Cleared Jul 11, 1985
ESP EMERGENCY CARE KIT
K852095
Emergency Situation Products
General & Plastic Surgery · 58d
Cleared Jul 11, 1985
MEDTRONIC MODEL 5867-1A
K852236 · KFJ
Medtronic Vascular
Cardiovascular · 50d
Cleared Jul 11, 1985
SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA
K852321
Sylvania Lighting Products
General & Plastic Surgery · 42d
Cleared Jul 11, 1985
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
K852375 · LRS
Ferris Mfg. Corp.
General & Plastic Surgery · 37d
Cleared Jul 11, 1985
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K852402 · FZX
North American Instrument Corp.
General & Plastic Surgery · 35d
Cleared Jul 11, 1985
MYELOGRAM PROCEDURE TRAY
K852501
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 29d
Cleared Jul 11, 1985
STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
K852541 · GFI
Storz Instrument Co.
General & Plastic Surgery · 27d
Cleared Jul 11, 1985
WALDMANN F85/100W UV6
K852576 · FTC
Sylvania Lighting Products
General & Plastic Surgery · 23d
Cleared Jul 11, 1985
APOLLO STERILE BLADES
K852661 · GES
Orthofab, Inc.
General & Plastic Surgery · 17d
Cleared Jul 11, 1985
WALDMANN F85/100W UV21
K852684 · FTC
Sylvania Lighting Products
General & Plastic Surgery · 16d
Cleared Jul 10, 1985
FASTUBE NERVE REGENERATION DEVICE
K850785 · JXI
Research Medical, Inc.
Neurology · 134d