FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75601–75624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 21, 2002
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K021479 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 13d
Cleared May 21, 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522 · DZL
Walter Lorenz Surgical, Inc.
Dental · 11d
Cleared May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS...
K021530 · FPA
Sterling Medivations, Inc.
General Hospital · 11d
Cleared May 20, 2002
GALILEO CAS/NAV TKR SYSTEM
K020298 · HAW
Plus Orthopedics
Neurology · 112d
Cleared May 20, 2002
AGILITY ANKLE REVISION PROSTHESIS
K020541 · HSN
Depuy, Inc.
Orthopedic · 90d
Cleared May 20, 2002
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K020574 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 88d
Cleared May 20, 2002
SYNTHES PILON PLATE
K020602 · HRS
Synthes
Orthopedic · 87d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · GWM
Medex, Inc.
Neurology · 70d