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
62353–62376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2006
OSTEO-LINK BONE VOID FILLER PELLETS
K060809 · MQV
Promed Advance Technology Co., Ltd.
Orthopedic · 101d
Cleared Jul 03, 2006
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
K061060 · FRO
Tissue Technologies Holdings, LLC
General & Plastic Surgery · 77d
Cleared Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · DIH
Roche Diagnostics Corp.
Toxicology · 75d
Cleared Jul 03, 2006
MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
K061116 · ITI
Mobilife, LLC
Physical Medicine · 73d
Cleared Jul 03, 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60...
K061156 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 68d
Cleared Jul 03, 2006
INJECTRA INJECTION NEEDLE
K061222 · FBK
Medi-Globe Corp.
Gastroenterology & Urology · 62d
Cleared Jul 03, 2006
I-CAT SCANNER
K061284 · MUH
Imaging Sciences Intl., Inc.
Radiology · 56d
Cleared Jul 03, 2006
STATARIUS, MODEL 001 003
K061292 · GCJ
Kinetic Surgical, LLC
General & Plastic Surgery · 55d
Cleared Jul 03, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN)...
K061327 · LON
Becton, Dickinson & CO
Microbiology · 52d
Cleared Jul 03, 2006
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
K061333 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 52d
Cleared Jul 03, 2006
POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE...
K061356 · MED
Advanced Infusion, Inc.
General Hospital · 49d
Cleared Jul 03, 2006
GE VIVID - I
K061525 · IYN
General Electric Co.
Radiology · 31d
Cleared Jul 03, 2006
DYNASTY ACETABULAR SHELL
K061547 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jul 03, 2006
I-STYLE BONE MARROW ASPIRATION NEEDLE
K061570 · KNW
Busse Hospital Disposables, Inc.
Gastroenterology & Urology · 27d
Cleared Jul 03, 2006
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
K061576 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 26d
Cleared Jul 03, 2006
MODIFICATION TO CD HORIZON SYSTEM
K061592 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Jul 03, 2006
LARGE UNI-CLIP STAPLE
K061594 · JDR
New Deal, S.A.
Orthopedic · 25d
Cleared Jul 03, 2006
SMOOTHSHAPES
K061603 · NUV
Biocellulase, Inc.
General & Plastic Surgery · 25d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · LCX
Unipath , Ltd.
Chemistry · 10d
Cleared Jun 30, 2006
LBI CATHETER SYSTEM
K053372 · QEZ
Lumen Biomedical, Inc.
Cardiovascular · 207d
Cleared Jun 30, 2006
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
K053373 · NHA
Atlantis Components, Inc.
Dental · 207d
Cleared Jun 30, 2006
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID...
K053571 · JBD
Interlab S.R.L.
Hematology · 190d
Cleared Jun 30, 2006
SFB & CFB IMPLANTS
K061003 · DZE
Nobel Biocare AB
Dental · 80d
Cleared Jun 30, 2006
SPEEDFLOW 0.2UM FILTER, MODEL 11214
K061115 · FPA
Gvs Spa
General Hospital · 70d