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
93049–93072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · KXT
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jul 30, 1997
INTRACAVITY NEEDLE GUIDE KIT
K955668 · ITX
Arlanda Medicinska Instrument Co. AB
Radiology · 595d
Cleared Jul 30, 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 313d
Cleared Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
K964282 · JMG
Boehringer Mannheim Corp.
Immunology · 275d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Jul 30, 1997
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
K971721 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · MBI
Arthrex, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · LZO
Zimmer, Inc.
Orthopedic · 79d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971791 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · HWC
Osteonics Corp.
Orthopedic · 76d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971802 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · LPH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 30, 1997
CODA AUTOMATED EIA ANALYZER
K972024 · JJI
Bio-Rad
Chemistry · 58d
Cleared Jul 30, 1997
STANDARD ENDOSCOPE
K972056 · GCJ
Laser Optik Systeme GmbH & Co. KG
General & Plastic Surgery · 58d
Cleared Jul 30, 1997
PHONAK MICROZOOM P 2
K972097 · ESD
Phonak, Inc.
Ear, Nose, Throat · 56d
Cleared Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC...
K972132 · LEG
Sigma Diagnostics, Inc.
Toxicology · 54d
Cleared Jul 30, 1997
AUDIFON H20 PC/AUDIFON H32 PP
K972552 · ESD
Trutone
Ear, Nose, Throat · 30d
Cleared Jul 29, 1997
WIRELESS EEG RECORDING SYSTEM MODEL W32
K963195 · GYE
Cme Telemetrix, Inc.
Neurology · 348d
Cleared Jul 29, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964886 · IYN
GE Medical Systems
Radiology · 235d
Cleared Jul 29, 1997
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
K970384 · IYE
Aktina Medical Physics Corp.
Radiology · 176d
Cleared Jul 29, 1997
ARGLAES FILM DRESSING
K970566 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 166d
Cleared Jul 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 139d
Cleared Jul 29, 1997
SCAR CARE
K971009 · MDA
Target Health, Inc.
General & Plastic Surgery · 131d
Cleared Jul 29, 1997
THE MIDVIEW-MEDCON'S DICOM VIEWER
K971181 · IZI
Medcon , Ltd.
Radiology · 120d