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
79297–79320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2001
VIADUCT MICROENDOSCOPE AND ACCESSORIES
K011189 · GCJ
Acueity, Inc.
General & Plastic Surgery · 89d
Cleared Jul 16, 2001
BIOPSY SITE MARKER
K011402 · FZP
Senorx, Inc.
General & Plastic Surgery · 70d
Cleared Jul 16, 2001
CAVEX COLORCHANGE
K011419 · ELW
Cavex Holland BV
Dental · 68d
Cleared Jul 16, 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT...
K011525 · JLW
Biosafe Laboratories, Inc.
Chemistry · 60d
Cleared Jul 16, 2001
CONCORD 72
K011626 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
CONCORD 82
K011628 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K011885 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 28d
Cleared Jul 16, 2001
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K011955 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 24d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · JDR
Xiros Plc
Orthopedic · 186d
Cleared Jul 13, 2001
SUPREMA POWERED WHEELCHAIR
K010600 · ITI
Luigi Chinetti
Physical Medicine · 135d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 95d
Cleared Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Jul 13, 2001
RAMBLER
K011401 · INI
Rambler Mobility, Inc.
Physical Medicine · 67d
Cleared Jul 13, 2001
MODEL 100 ACTIVITY MONITOR
K011429 · GYD
Telecom Medical, Inc.
Neurology · 65d
Cleared Jul 13, 2001
MEDLINE GROUNDING PAD
K011515 · JOS
Medline Industries, Inc.
General & Plastic Surgery · 57d
Cleared Jul 13, 2001
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
K011779 · DXN
Avid Care Corp.
Cardiovascular · 36d
Cleared Jul 13, 2001
LIFECARD CF 7 DAY
K011837 · MWJ
Reynolds Medical , Ltd.
Cardiovascular · 31d
Cleared Jul 13, 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · DRF
Zynergy Cardio Vasular (Zcv), Inc.
Cardiovascular · 30d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · HSD
Tornier
Orthopedic · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 18d