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
150985–151008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1984
STONE, INSTRUMENT HONING
K844379
Treace Medical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 29, 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 16d
Cleared Nov 29, 1984
POWER PACK 160 SIEMENS-ELEMA AB
K844590 · CBK
Siemens Elema AB
Anesthesiology · 3d
Cleared Nov 28, 1984
MODEL 800-A VERI/PPR
K840099 · GZJ
Verite
Neurology · 323d
Cleared Nov 28, 1984
CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2
K842754 · FLG
Custom Ultrasonics
General Hospital · 135d
Cleared Nov 28, 1984
MIXING CONTAINER
K843954 · KPE
American Mcgaw
General Hospital · 50d
Cleared Nov 28, 1984
COLOR OPTIC CORNEAL EYE SHIELD
K843961 · HOY
Colors IN Optics , Ltd.
Ophthalmic · 48d
Cleared Nov 28, 1984
DERATA MEDI-JECTOR III
K844111 · KZE
Derata Corp.
General Hospital · 36d
Cleared Nov 28, 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113 · FOZ
Parke-Davis Co.
General Hospital · 36d
Cleared Nov 28, 1984
DESERET DENTRAL LINE CATHETER
K844219 · FOZ
Parke-Davis Co.
General Hospital · 28d
Cleared Nov 28, 1984
NUTRIBAG MIXING CONTAINER -2000 ML
K844410 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 14d
Cleared Nov 27, 1984
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · DTD
Siemens Elema AB
Cardiovascular · 250d
Cleared Nov 27, 1984
ENZYME IMMUNOASSAY FOR DETECTION HORM
K841545 · CEP
Btc Diagnostics, Inc.
Chemistry · 225d
Cleared Nov 27, 1984
SCATAID
K842706 · DXG
Sc Applied Technology, Inc.
Cardiovascular · 138d
Cleared Nov 27, 1984
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K842979 · HQC
CooperVision, Inc.
Ophthalmic · 120d
Cleared Nov 27, 1984
IOCARE IRRIGATION/ASPIRATION PACK
K843275 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
IOCARE PHACOEMULSIFICATION PACK
K843277 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
IOCARE ULTRASONIC TITANIUM TIPS
K843278 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
FLOOR MOUNTED X-RAY TUBESTAND
K843335 · IYB
Medicor USA , Ltd.
Radiology · 92d
Cleared Nov 27, 1984
PORTA-STAT
K843340 · IWY
Porta-Stat, Inc.
Radiology · 92d
Cleared Nov 27, 1984
MENDEZ U/S CYSTOTOME
K843386 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Nov 27, 1984
STRESS CONTROL BIOFEEDBACK CARD
K843413 · HCC
Pilgrim Plastic Products Co.
Neurology · 88d
Cleared Nov 27, 1984
MEI MAMMOGRAPHY SYS MX-2049
K843437 · IZH
Moti Enterprises, Inc.
Radiology · 84d
Cleared Nov 27, 1984
ULTRA LYTE SODIUM REAGENT KIT
K843453 · JGS
Ultra Quest Diagnostics, Inc.
Chemistry · 83d