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
108265–108288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1994
FLOWGUN ELECTROCAUTERY PROBE HANDLE
K935970 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 154d
Cleared May 16, 1994
FLOWGUN ELECTROCAUTERY PROBES
K935971 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 154d
Cleared May 16, 1994
OPTODENT/OPTOGNATH
K936058 · ELM
Spectrum Healthcare Group
Dental · 147d
Cleared May 16, 1994
MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES,...
K936248 · GCJ
Medicon Instruments, Inc.
General & Plastic Surgery · 137d
Cleared May 16, 1994
GALILEO ENDOSCOPES
K936279 · GCJ
Galileo Electro-Optics Corp.
General & Plastic Surgery · 230d
Cleared May 16, 1994
SURESOFT SURGICAL GLOVES
K940218 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 122d
Cleared May 16, 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · ERL
Stryker Corp.
Ear, Nose, Throat · 88d
Cleared May 16, 1994
BASICS ENDOSCOPY SYSTEM
K940911 · KGE
Cox Medical Ent., Inc.
Gastroenterology & Urology · 80d
Cleared May 16, 1994
ACUFEX LINEAR/ROTARY INSTRUMENTS
K940981 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared May 16, 1994
ACUFEX(R) ARTHROPLASTY INSTRUMENTS
K940985 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared May 16, 1994
VENOSCOPE
K941035 · HJN
Trinity Partners, LLC
Ophthalmic · 70d
Cleared May 16, 1994
EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT
K941134 · FEB
H & C Chemical, Inc.
General Hospital · 68d
Cleared May 16, 1994
DISPOSABLE PROPHYLAXIS ANGLE
K941189 · EGS
Team Technologies, Inc.
Dental · 63d
Cleared May 16, 1994
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
K941364 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 56d
Cleared May 16, 1994
HSV LAPAROSCOPY SET
K941541 · GCJ
Henke Sass Wolf of America, Inc.
General & Plastic Surgery · 48d
Cleared May 16, 1994
JARIT RECOMMENDED SINUS INSTRUMENTS
K941565 · EOB
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared May 16, 1994
URI-CATH CATHETER
K941672 · GBM
Gesco Intl., Inc.
Gastroenterology & Urology · 41d
Cleared May 16, 1994
HSW LAPAROSCOPE AND ACCESSORIES
K941967 · GCJ
Henke-Sass, Wolf GmbH
General & Plastic Surgery · 24d
Cleared May 16, 1994
DISPOSABLE SUCTION PROBE
K942061 · JOL
United States Surgical, A Division of...
General Hospital · 17d
Cleared May 13, 1994
PRO-CONNECT
K932269 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 367d
Cleared May 13, 1994
CAPASEE
K933747 · IYO
Toshiba America Medical Systems, In.C
Radiology · 283d
Cleared May 13, 1994
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · JFT
Ciba Corning Diagnostics Corp.
Chemistry · 254d
Cleared May 13, 1994
NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
K934426 · ETN
Xomed-Treace, Inc.
Ear, Nose, Throat · 245d
Cleared May 13, 1994
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638 · JOP
Koven Technology, Inc.
Cardiovascular · 231d