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
99337–99360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1996
MORELL INJECTOR
K951870 · CAZ
Incutech, Inc.
Anesthesiology · 276d
Cleared Jan 22, 1996
ISOLA SYSTEM
K952236 · MNH
Acromed Corp.
Orthopedic · 255d
Cleared Jan 22, 1996
6 WATT HOLMIUM LASER SYSTEM
K952489 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 237d
Cleared Jan 22, 1996
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
K952495 · LXH
Orthopedic Systems, Inc.
Orthopedic · 237d
Cleared Jan 22, 1996
THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK
K952906 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 213d
Cleared Jan 22, 1996
THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK
K952959 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 210d
Cleared Jan 22, 1996
BETA HIP PROSTHESIS
K953337 · LPH
Zimmer, Inc.
Orthopedic · 189d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953354 · GXY
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 22, 1996
EMG RECORDING RING ELECTRODE
K953356 · GXY
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953361 · GXY
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 22, 1996
OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
K953913 · HRX
Optus, Inc.
Orthopedic · 154d
Cleared Jan 22, 1996
ENDOSCOPIC CATHETER
K953967 · ODD
Act Medical, Inc.
Gastroenterology & Urology · 153d
Cleared Jan 22, 1996
ACUPLUS
K954334 · GZJ
S.H.P. Intl. Pty., Ltd.
Neurology · 126d
Cleared Jan 22, 1996
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 108d
Cleared Jan 22, 1996
MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER
K954904 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 89d
Cleared Jan 22, 1996
S-ROM FEMORAL HIP STEM - SIZE 14 X 8
K954935 · LPH
Joint Medical Products Corp.
Orthopedic · 87d
Cleared Jan 22, 1996
OLYMPUS BASKET GRASPERS
K955063 · OCZ
Olympus America, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · HWE
3M Company
Orthopedic · 76d
Cleared Jan 22, 1996
SURGICAL CUTTER
K955168 · GEI
Promex, Inc.
Obstetrics & Gynecology · 70d
Cleared Jan 22, 1996
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY
K955174 · GET
Sodem Diffusion SA
General & Plastic Surgery · 70d
Cleared Jan 22, 1996
LAPAROSCOPIC KNITTER
K955490 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 80d
Cleared Jan 22, 1996
BIPOLAR CUTTER
K955618 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 42d
Cleared Jan 22, 1996
MEDTRONIC SHERPA GUIDING CATHETER
K955651 · DQY
Medtronics Interventional Vascular
Cardiovascular · 41d
Cleared Jan 19, 1996
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
K950990 · DTQ
Stoeckert Instrumente
Cardiovascular · 322d