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
67729–67752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2004
DIGITAL DETECTOR, MODEL GR17
K042821 · MQB
Anrad Corp.
Radiology · 10d
Cleared Oct 21, 2004
COLLAGEN-ORC ANTIMICROBIAL MATRIX
K033523 · FRO
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 349d
Cleared Oct 21, 2004
POLYMEDCO OC AUTO MICRO 80 FOB TEST
K041408 · OOX
Polymedco, Inc.
Hematology · 147d
Cleared Oct 21, 2004
AMERICAN BANTEX, MODEL MS 3
K042104 · INI
American Bantex Corp.
Physical Medicine · 78d
Cleared Oct 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · GGN
Dade Behring, Inc.
Hematology · 66d
Cleared Oct 21, 2004
IMPLANTMASTER
K042212 · LLZ
I-Dent
Radiology · 66d
Cleared Oct 21, 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221...
K042305 · MQV
Ossacur AG
Orthopedic · 57d
Cleared Oct 21, 2004
LITESTREAM 500E
K042444 · IOR
Pride Mobility Products Corp.
Physical Medicine · 42d
Cleared Oct 21, 2004
HOVEROUND MPV-5 POWERCHAIR
K042545 · ITI
Hoveround Corp.
Physical Medicine · 31d
Cleared Oct 21, 2004
IV ADMINISTRATION SET B400 SP
K042693 · FPA
Codan US Corp.
General Hospital · 21d
Cleared Oct 21, 2004
RADIOTHERAPY SOLUTION BASED ON CR
K042779 · IXK
Agfa Corp.
Radiology · 15d
Cleared Oct 20, 2004
MEGA PURE CART
K031832 · FIP
Mega Services
Gastroenterology & Urology · 495d
Cleared Oct 20, 2004
WEST NILE VIRUS IGG INDIRECT ELISA
K041068 · NOP
Panbio Limited
Microbiology · 177d
Cleared Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961 · HWC
Scandius Biomedical, Inc.
Orthopedic · 91d
Cleared Oct 20, 2004
AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
K041963 · BTT
American Bantex Corp.
Anesthesiology · 91d
Cleared Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · JDR
Biomet, Inc.
Orthopedic · 89d
Cleared Oct 20, 2004
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
K042002 · DQK
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Oct 20, 2004
IBD-SCAN
K042071 · DEG
Techlab, Inc.
Immunology · 79d
Cleared Oct 20, 2004
MI PASTE
K042200 · EJR
GC America, Inc.
Dental · 68d
Cleared Oct 20, 2004
SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000
K042369 · IYN
Sonoscape Company Limited
Radiology · 50d
Cleared Oct 20, 2004
RSA-CMS
K042383 · LLZ
Medis Medical Imaging Systems BV
Radiology · 49d
Cleared Oct 20, 2004
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484 · LMA
Nai Technology Products
Radiology · 37d
Cleared Oct 20, 2004
PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004,...
K042658 · NHA
Nobel Biocare Uas, Inc.
Dental · 22d
Cleared Oct 20, 2004
IONOFIL PLUS AC
K042669 · EMA
Voco GmbH
Dental · 21d