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
82609–82632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · MSX
Datex-Ohmeda, Inc.
Cardiovascular · 136d
Cleared Jul 13, 2000
ISOLETTE INFANT INCUBATOR, MODEL C2HS
K001242 · FMZ
Hill-Rom Air-Shields
General Hospital · 86d
Cleared Jul 13, 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · MWI
Welch Allyn, Inc.
Cardiovascular · 85d
Cleared Jul 13, 2000
RETCAM II
K001275 · HKI
Massie Research Laboratories, Inc.
Ophthalmic · 84d
Cleared Jul 13, 2000
ISLAND BIOSURGICAL BNS KIT #3
K001583 · KOD
Island Biosurgical, LLC
Gastroenterology & Urology · 52d
Cleared Jul 13, 2000
FOCUS
K001729 · EHD
Instrumentarium Corp.
Radiology · 36d
Cleared Jul 13, 2000
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001747 · LLZ
Barco NV Display Systems
Radiology · 35d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · JIS
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 13, 2000
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
K002003 · IYN
Atl Ultrasound, Inc.
Radiology · 13d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · IYO
Quantel Medical
Radiology · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · MUJ
Brainlab AG
Radiology · 197d
Cleared Jul 12, 2000
AMT THERAPEUTIC TABLE, MODEL 748AMT
K001401 · ITH
Amt Mfg., Inc.
Physical Medicine · 70d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · DKZ
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 12, 2000
AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
K001502 · BZC
Erich Jaeger GmbH
Anesthesiology · 58d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 12, 2000
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K001524 · MQG
Thermoquest Corp.
Obstetrics & Gynecology · 57d
Cleared Jul 12, 2000
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · CAZ
Arrow Intl., Inc.
Anesthesiology · 50d
Cleared Jul 12, 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · DXF
NuMED, Inc.
Cardiovascular · 27d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d