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
64321–64344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2005
KOKO LEGEND
K051572 · BZG
Pulmonary Data Services, Inc.
Anesthesiology · 156d
Cleared Nov 17, 2005
FLEXI-LITE, MODEL FL-V1.2
K051759 · CBF
Performance Hyperbarics
Anesthesiology · 141d
Cleared Nov 17, 2005
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · MHJ
Techlab, Inc.
Microbiology · 127d
Cleared Nov 17, 2005
IMC SURGICAL DRAPES
K052169 · KKX
International Medsurg Connection, Inc.
General Hospital · 100d
Cleared Nov 17, 2005
STIMUPLEX HNS-12, MODEL 4892098
K052313 · BXN
Stockert GmbH
Anesthesiology · 84d
Cleared Nov 17, 2005
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
K052377 · DQA
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 79d
Cleared Nov 17, 2005
EZ-IO
K052408 · FMI
Vidacare Corporation
General Hospital · 77d
Cleared Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413 · KNS
Medtronic Vascular
Gastroenterology & Urology · 76d
Cleared Nov 17, 2005
IMC SURGICAL GOWNS
K052550 · FYA
Intl. Medsurg Connection, Inc.
General Hospital · 62d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
K052565 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 59d
Cleared Nov 17, 2005
IMAGECAST PACS
K052618 · LLZ
Idx Systems Corp.
Radiology · 55d
Cleared Nov 17, 2005
TIGECYCLINE 15UG BBL SENSI-DISC
K052853 · JTN
Becton, Dickinson & CO
Microbiology · 37d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K052899 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 34d
Cleared Nov 17, 2005
CR-PRO
K052938 · MQB
Eradlink, Inc.
Radiology · 28d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH
GE Medical Systems
Radiology · 22d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042 · MOS
Medrad, Inc.
Radiology · 20d
Cleared Nov 16, 2005
INFINITY ALPHA
K051658 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Nov 16, 2005
CONTRAST MEDIA TRANSFER SETS
K052252 · FPA
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Nov 16, 2005
STERLING INTERFERENC SCREW HT
K052405 · HWC
Regeneration Technologies, Inc.
Orthopedic · 76d
Cleared Nov 16, 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · NLH
Alliance Medical Corp.
Cardiovascular · 75d
Cleared Nov 16, 2005
PIEZOSURGERY
K052518 · ELC
Piezosurgery S.R.L.
Dental · 63d
Cleared Nov 16, 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
K052537 · LLZ
American Medical Sales, Inc.
Radiology · 62d
Cleared Nov 16, 2005
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052603 · NLH
Alliance Medical Corp.
Cardiovascular · 56d
Cleared Nov 16, 2005
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
K052624 · HRS
Inion , Ltd.
Orthopedic · 54d