FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
107233–107256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1994
STERIKING, SEE & PEEL
K922440 · KCT
Cox Sterile Products, Inc.
General Hospital · 857d
Cleared Sep 26, 1994
EPCOR
K930786 · DRW
Siemens Medical Solutions USA, Inc.
Cardiovascular · 587d
Cleared Sep 26, 1994
THE OSTEOREPORT
K934040 · KGI
Woodson and Associates, LLC
Radiology · 404d
Cleared Sep 26, 1994
DANTEC 13R45 BAR ELECTRODE
K934580 · GXY
Dantec Medical, Inc.
Neurology · 368d
Cleared Sep 26, 1994
SHOE COVER
K940226 · LYU
Derekduck Industries Corp.
General Hospital · 255d
Cleared Sep 26, 1994
BOUFFANT CAP
K940228 · LYU
Derekduck Industries Corp.
General Hospital · 255d
Cleared Sep 26, 1994
THE BIOPSY TOOL
K941563 · FCG
Citation Medical Corp.
Gastroenterology & Urology · 178d
Cleared Sep 26, 1994
IGM RHEUMATOID FACTOR
K942272 · DHR
Immco Diagnostics, Inc.
Immunology · 139d
Cleared Sep 26, 1994
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM
K943043 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 91d
Cleared Sep 26, 1994
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY
K943044 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 91d
Cleared Sep 26, 1994
PATIENT EXAMINATION GLOVES
K943434 · LYY
Pacewell Sdn Bhd
General Hospital · 70d
Cleared Sep 26, 1994
SURGI-LINK ELECTROSURGICAL ELECTRODE
K944433 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 14d
Cleared Sep 23, 1994
FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET
K926019 · KGI
Norland Corp.
Radiology · 662d
Cleared Sep 23, 1994
VARIAN RMS-2000, RELEASE 2.5
K930513 · IYE
Varian Assoc., Inc.
Radiology · 599d
Cleared Sep 23, 1994
VARIAN ORIGAMI, VERSION 1.0
K932501 · IYE
Varian Assoc., Inc.
Radiology · 486d
Cleared Sep 23, 1994
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
K933445 · HJM
Storz Instrument Co.
Ophthalmic · 437d
Cleared Sep 23, 1994
CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS...
K934610 · FJS
Tabex Industries, Inc.
Gastroenterology & Urology · 361d
Cleared Sep 23, 1994
PATLAK & FDG AUTORADIOGRAPHIC
K936001 · KPS
GE Medical Systems
Radiology · 282d
Cleared Sep 23, 1994
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
K942146 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 143d
Cleared Sep 23, 1994
IRRIGATION/ASPIRATION INSTRUMENT
K942306 · GCJ
Megadyne Medical Products, Inc.
General & Plastic Surgery · 133d
Cleared Sep 23, 1994
MIRACLE-EAR IMPRESSION MATERIAL KIT
K942523 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 161d
Cleared Sep 23, 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956 · HWE
Stryker Corp.
Orthopedic · 92d
Cleared Sep 23, 1994
BIPOLAR ELECTROSURGICAL PENCIL
K943031 · HQO
Boston Surgical Products, Inc.
Ophthalmic · 88d
Cleared Sep 23, 1994
QUAD PELVIS COIL
K943321 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 74d