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
115081–115104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1992
FUJINON FORCEPS -- MODIFICATION
K922396 · FCL
Hobbs Medical, Inc.
Gastroenterology & Urology · 205d
Cleared Dec 10, 1992
TORQUE DEVICE
K922536 · DQX
Procedure Products, Inc.
Cardiovascular · 196d
Cleared Dec 10, 1992
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
K922550 · KQX
Verimed Holdings, Inc.
Neurology · 195d
Cleared Dec 10, 1992
SCIMED SIDELINER
K922706 · DQX
Scimed
Cardiovascular · 188d
Cleared Dec 10, 1992
NEER TYPE SHOULDER PROSTHESIS SYSTEM
K922865 · KWT
Osteo Technology, Inc.
Orthopedic · 189d
Cleared Dec 10, 1992
3DSCOPE
K923160 · FWF
American Surgical Technologies Corp.
General & Plastic Surgery · 164d
Cleared Dec 10, 1992
OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED
K923348 · ITX
Zeiss Humphrey System
Radiology · 196d
Cleared Dec 10, 1992
TRACHEOSTOMY CARE SET WITH GLOVES
K923834 · BTO
American Healthcare Corp.
Anesthesiology · 132d
Cleared Dec 10, 1992
EUB-405
K924126 · IYO
Hitachi Medical Systems America, Inc.
Radiology · 115d
Cleared Dec 10, 1992
BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM
K924188 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 112d
Cleared Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600 · JXG
Cordis Corp.
Neurology · 90d
Cleared Dec 09, 1992
TUM-E-VAC BITE BLOCK
K921946 · JXL
Ethox Corp.
Neurology · 226d
Cleared Dec 09, 1992
ETHYL ALCOHOL CALIBRATORS & CONTROL
K924733 · DNN
Diagnostic Reagents, Inc.
Toxicology · 78d
Cleared Dec 09, 1992
COLLIMATOR LIGHT SOURCE
K924759 · IZT
Denar Corp.
Radiology · 77d
Cleared Dec 08, 1992
DISPOSABLE MONOPLAR MEDDLE ELECTRODES
K915741 · GXE
Dantec Medical, Inc.
Neurology · 354d
Cleared Dec 08, 1992
A.C.S. SUTURE REMOVAL KIT
K915827 · MCZ
American Carolina Stamping
General & Plastic Surgery · 344d
Cleared Dec 08, 1992
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869 · MJN
Research Medical, Inc.
Cardiovascular · 343d
Cleared Dec 08, 1992
IQ SYSTEM
K922218 · DXG
Renaissance Technology, Inc.
Cardiovascular · 210d
Cleared Dec 08, 1992
USCI SUPER 9 PTCA GUIDING CATHETER
K922541 · DQI
C.R. Bard, Inc.
General Hospital · 193d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · MAV
Boston Scientific Corp
Cardiovascular · 190d
Cleared Dec 08, 1992
SENSOR GUI
K923519 · BSZ
Hospitronic
Anesthesiology · 161d
Cleared Dec 08, 1992
SONOMED 4000P ULTRASONIC PACHYMETER
K924311 · IYO
Sonomed, Inc.
Radiology · 104d
Cleared Dec 08, 1992
ENDO TRACHEA TUBE FIXATION
K924551 · CBH
M. Imonti and Associates Inc.,
Anesthesiology · 90d
Cleared Dec 08, 1992
SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER
K924591 · DQY
Schneider Intl., Ltd.
Cardiovascular · 89d