Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76201–76224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2002
HDM97
K020908 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 22, 2002
HDM99
K020909 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 22, 2002
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
K021013 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 54d
Cleared May 22, 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
K021082 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 49d
Cleared May 22, 2002
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
K021225 · DXN
Rossmax International , Ltd.
Cardiovascular · 34d
Cleared May 22, 2002
ECLIPSE, HELIOS OPTION
K021268 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 26d
Cleared May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
K021435 · MWI
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared May 22, 2002
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
K021447 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 16d
Cleared May 22, 2002
OCO DENTAL IMPLANT
K021460 · NHA
"O" Co., Inc.
Dental · 15d
Cleared May 22, 2002
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K021465 · LYY
Industrial Clothings, Ltd.
General Hospital · 15d
Cleared May 22, 2002
HISPEED DUAL
K021491 · JAK
Ge Medical Systems, Inc.
Radiology · 13d
Cleared May 22, 2002
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT...
K021591 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 7d
Cleared May 21, 2002
TST - SUPPRESSOR MODEL #1000
K013827 · KLW
Neurosim Limited
Ear, Nose, Throat · 183d
Cleared May 21, 2002
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K013897 · MQB
Bio-Scan S.A
Radiology · 179d
Cleared May 21, 2002
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
K013982 · KRR
Kinamed, Inc.
Orthopedic · 169d
Cleared May 21, 2002
MEDAMICUS AXIA RSN
K020563 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared May 21, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND...
K020790 · MOS
Surgi-Vision, Inc.
Radiology · 71d
Cleared May 21, 2002
ULTIMA TENS XL-A1
K020846 · GZJ
Tenscare, Ltd.
Neurology · 67d
Cleared May 21, 2002
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
K020993 · MOS
Magna-Lab, Inc.
Radiology · 55d
Cleared May 21, 2002
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
K021262 · MOS
Usa Instruments, Inc.
Radiology · 29d
Cleared May 21, 2002
SIB CATHETER, MODEL 61-7005
K021272 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 29d
Cleared May 21, 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared May 21, 2002
DEXACARE G4
K021331 · KGI
Osteometer Meditech, Inc.
Radiology · 25d