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
160681–160704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1982
COUNTER-ROTATION SYSTEM
K821256 · ITN
The Langer Group
Physical Medicine · 54d
Cleared Jun 23, 1982
VITASAN
K821259 · FQL
Selomas, Inc.
General Hospital · 54d
Cleared Jun 23, 1982
VITOFIT
K821260 · FQL
Selomas, Inc.
General Hospital · 54d
Cleared Jun 23, 1982
TRANSDUCER FILTER
K821268 · FIB
Cp Medical
Gastroenterology & Urology · 51d
Cleared Jun 23, 1982
ECHO, MODEL MM-1000
K821383 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 44d
Cleared Jun 23, 1982
MAHURKAR SUBCLAVIAN CATHETER
K821400 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 23, 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · DHB
Ventrex Laboratories, Inc.
Immunology · 40d
Cleared Jun 23, 1982
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · KRO
C.R. Bard, Inc.
Orthopedic · 36d
Cleared Jun 23, 1982
STERILE CATH CARE KIT
K821500 · KDD
Pro-Pak
General & Plastic Surgery · 35d
Cleared Jun 23, 1982
THERMAL WELL TEMPERATURE SENSOR
K821504 · FLL
Mon-A-Therm, Inc.
General Hospital · 34d
Cleared Jun 23, 1982
DESERET UNIVERSAL LUER LOCK
K821525 · KGZ
Warner-Lambert Co.
General & Plastic Surgery · 33d
Cleared Jun 23, 1982
SHUR-STRIP APPLICATOR
K821763 · FPX
Shur Medical Corp.
General & Plastic Surgery · 8d
Cleared Jun 23, 1982
PEDICRAFT BED, MODEL B2944
K821773 · FMS
Pedicraft, Inc.
General Hospital · 7d
Cleared Jun 22, 1982
ACCURETTE
K820641 · HFF
Axcan Scientific Corp.
Obstetrics & Gynecology · 106d
Cleared Jun 22, 1982
C-101-P
K820939 · DXY
Coratomic, Inc.
Cardiovascular · 77d
Cleared Jun 22, 1982
INVERCHAIR
K821002 · ITH
Inverchair Marketing, Inc.
Physical Medicine · 75d
Cleared Jun 22, 1982
VARIOUS STERILE BIOPSY ASPIRATION NEED
K821017 · GAA
Medsurg Industries, Inc.
General & Plastic Surgery · 71d
Cleared Jun 22, 1982
FLUORO-CEP
K821060
Zeus Scientific, Inc.
Chemistry · 68d
Cleared Jun 22, 1982
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
K821092 · DGC
Clinical Assays, Inc.
Chemistry · 64d
Cleared Jun 22, 1982
DC PACK TM
K821134 · HFC
Seamless Hospital Products Co.
Obstetrics & Gynecology · 63d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK
K821229 · JTN
General Diagnostics
Microbiology · 56d
Cleared Jun 22, 1982
HOFFMAN UNIVERSAL FOOT SUPPORT
K821252 · KQZ
Howmedica Corp.
Orthopedic · 53d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG SENSIT- DISCS
K821262 · JTN
Difco Laboratories, Inc.
Immunology · 50d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG SENSI-DISC
K821264 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 50d