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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
145489–145512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1986
IMZ INTRAMOBILE CYLINDER IMPLANT
K855032 · DZE
Interpore Intl.
Dental · 77d
Cleared Mar 03, 1986
V-TREND KIT STAPH LATEX TEST
K855220 · JWX
Texas Immunology, Inc.
Microbiology · 63d
Cleared Mar 03, 1986
QUADRA-TITER I.D.
K860208 · JSS
Microtech Medical Systems, Inc.
Microbiology · 40d
Cleared Mar 03, 1986
HEMOGLOBIN REAGENT SET
K860475 · KHG
Sterling Diagnostics, Inc.
Hematology · 24d
Cleared Mar 03, 1986
SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
K860522 · BZG
Teledyne Avionics Div. of Teledyne
Anesthesiology · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · JTN
Difco Laboratories, Inc.
Microbiology · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSI DISC
K860536 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Mar 03, 1986
POLYPET
K860617 · JTC
Instrumed, Inc.
Microbiology · 12d
Cleared Mar 03, 1986
CELLGRO HEPES BUFFER SOLUTION
K860623 · KIT
Mediatech, Inc.
Pathology · 12d
Cleared Mar 03, 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · KRI
American Bentley
Cardiovascular · 7d
Cleared Feb 28, 1986
SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM
K853178 · HCB
Oxford Medilog, Inc.
Neurology · 213d
Cleared Feb 28, 1986
MOLDTEC STIMULATOR
K853757 · DRT
Moldtec, Inc.
Cardiovascular · 172d
Cleared Feb 28, 1986
DOBE (MODIFIED)
K853993 · DRX
Phoenix Medical Technology, Inc.
Cardiovascular · 154d
Cleared Feb 28, 1986
TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE
K854013 · DXH
Medrand, Inc.
Cardiovascular · 151d
Cleared Feb 28, 1986
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · JLS
Immuchem Corp.
Chemistry · 144d
Cleared Feb 28, 1986
FASTENS(TM)
K854316 · GZJ
Medical Devices, Inc.
Neurology · 123d
Cleared Feb 28, 1986
WEP 7604 TELEMETRY MONITOR
K854369 · DXH
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
VM 781 SLAVE SCOPE
K854372 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482 · DXY
Medtronic Vascular
Cardiovascular · 113d
Cleared Feb 28, 1986
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K854581 · EOQ
Machida America, Inc.
Ear, Nose, Throat · 105d
Cleared Feb 28, 1986
COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
K854626 · BZC
Compumed, Inc.
Anesthesiology · 102d
Cleared Feb 28, 1986
2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE
K854743 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 95d
Cleared Feb 28, 1986
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 94d
Cleared Feb 28, 1986
INSTAPURE
K854817 · FRF
Teledyne, Inc.
General Hospital · 87d