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
68689–68712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2004
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
K041454 · HRX
Kyphon, Inc.
Orthopedic · 38d
Cleared Jul 09, 2004
PROFEMUR S HIP STEM
K041586 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Jul 09, 2004
DDS-ZR
K041645 · EIH
Charles Scharf
Dental · 22d
Cleared Jul 09, 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · FRN
Baxter Healthcare Corporation
General Hospital · 11d
Cleared Jul 08, 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · HAW
Biomet, Inc.
Neurology · 428d
Cleared Jul 08, 2004
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
K031701 · NEI
Osteomed LP
Dental · 402d
Cleared Jul 08, 2004
MDI TRIGGER GUARD
K040439 · CAF
North American Technical Services...
Anesthesiology · 140d
Cleared Jul 08, 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · LZA
Medline Industries, Inc.
General Hospital · 98d
Cleared Jul 08, 2004
INJECTOR NEEDLE/SNARE
K040961 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 08, 2004
LEONARDO
K040970 · LLZ
Siemens Medical Systems, Inc.
Radiology · 85d
Cleared Jul 08, 2004
KINETDX
K041029 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 78d
Cleared Jul 08, 2004
SYNTHES (USA) CHRONOS
K041350 · GXP
Synthes (Usa)
Neurology · 49d
Cleared Jul 08, 2004
CRONO AND CRONO, MODEL 30
K041414 · FRN
Cane S.R.L.
General Hospital · 42d
Cleared Jul 08, 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K041622 · BSZ
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Jul 08, 2004
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
K041688 · IYN
General Electric Co.
Radiology · 16d
Cleared Jul 07, 2004
WATERLASE
K031140 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 454d
Cleared Jul 07, 2004
CMI MAGNETOCARDIOGRAPH
K033488 · DPS
Cmi Cardiomag Imaging, Inc.
Cardiovascular · 246d
Cleared Jul 07, 2004
COPSIOS BONE VOID FILLER (BVF)
K033679 · MQV
Centerpulse Spine-Tech, Inc.
Orthopedic · 226d
Cleared Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926 · MQP
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Jul 07, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · LIH
Biomedical Life Systems, Inc.
Neurology · 187d
Cleared Jul 07, 2004
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND...
K040237 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 159d
Cleared Jul 07, 2004
ZIRCON-F PROPHYLAXIS PASTE
K040988 · EJR
Pascal Co., Inc.
Dental · 83d
Cleared Jul 07, 2004
SUILE OINTMENT WOUND DRESSING
K041013 · FRO
Hedonist Biochemical Technologies...
General & Plastic Surgery · 78d
Cleared Jul 07, 2004
CADSTREAM VERSION 3.1
K041020 · LNH
Confirma, Inc.
Radiology · 78d