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
144697–144720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1986
LEE ELECTRONICS PAL
K854637 · ESD
Lee Electronics
Ear, Nose, Throat · 161d
Cleared Apr 29, 1986
BARD PARKER PERFUSION CATHETER
K855201 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 123d
Cleared Apr 29, 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 89d
Cleared Apr 29, 1986
CARDIO-COOL
K860523 · DTR
Bio-Vascular, Inc.
Cardiovascular · 76d
Cleared Apr 29, 1986
SARNS OXYGENATOR SYSTEM
K860539 · DTZ
3M Health Care, Sarns
Cardiovascular · 76d
Cleared Apr 29, 1986
SPACELABS MEDICAL WORKSTATION
K860834 · DSI
Spacelabs, Inc.
Cardiovascular · 55d
Cleared Apr 29, 1986
SUBCLAVIAN INTRODUCER SET
K860898 · DYB
Infusaid Corp.
Cardiovascular · 50d
Cleared Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · CEP
Hybritech, Inc.
Chemistry · 43d
Cleared Apr 29, 1986
PERCUTANEOUS CATHETERS
K861008 · DQY
Micor, Inc.
Cardiovascular · 42d
Cleared Apr 29, 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 29, 1986
NEONATAL UNILET
K861243 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 27d
Cleared Apr 28, 1986
CHLAMYSET ANTIGEN
K853401 · LJP
Orion Corp.
Microbiology · 259d
Cleared Apr 28, 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 181d
Cleared Apr 28, 1986
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
K860287 · DXN
Healthcheck Corp.
Cardiovascular · 90d
Cleared Apr 28, 1986
TSHK-NN RIA KIT
K860824 · JLW
Cis-Us, Inc.
Chemistry · 55d
Cleared Apr 28, 1986
GUIDE WIRE INTRODUCER
K860841 · DQX
Target Therapeutics
Cardiovascular · 55d
Cleared Apr 28, 1986
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · CGI
Sclavo, Inc.
Chemistry · 49d
Cleared Apr 28, 1986
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K861025 · KDQ
Boehringer Laboratories
General Hospital · 41d
Cleared Apr 28, 1986
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
K861104 · BYE
Med Air Technology, Inc.
Anesthesiology · 35d
Cleared Apr 28, 1986
MULTI-SPIKE
K861203 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 27d
Cleared Apr 28, 1986
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231 · CKA
Hi Chem, Inc.
Chemistry · 27d
Cleared Apr 28, 1986
AST REAGENT CARTRIDGE
K861283 · CIT
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
AP REAGENT CARTRIDGE
K861284 · CJE
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
ULTRA-VIOLET GOGGLETS
K861333
Health Saver Products
Ophthalmic · 19d