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
92545–92568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 29, 1997
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
K971571 · KDN
Waters Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · NAE
Coloplast Corp.
General & Plastic Surgery · 89d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671 · HLI
Heidelberg Engineering
Ophthalmic · 83d
Cleared Jul 29, 1997
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
K971687 · FJK
National Medical Care, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 29, 1997
VG 200 VIDEO GASTROSCOPE
K971734 · FDS
Welch Allyn, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 29, 1997
WELCON HUE-VU URINARY DRAINAGE BAG
K971764 · KNX
Welcon, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 29, 1997
BONE AND MARROW COLLECTION SYSTEM KIT
K971782 · GEY
Biomedical Ent., Inc.
General & Plastic Surgery · 76d
Cleared Jul 29, 1997
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
K971916 · MDA
Medical Z, S.A.
General & Plastic Surgery · 67d
Cleared Jul 29, 1997
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION...
K972069 · FQH
Stryker Instruments
General Hospital · 56d