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
63193–63216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2006
SUPER SHEATH XL INTRODUCER SHEATH
K060190 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 70d
Cleared Apr 04, 2006
MODIFICATION TO INFINITY EXPLORER
K060254 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 62d
Cleared Apr 04, 2006
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
K060342 · DXN
Rossmax International , Ltd.
Cardiovascular · 53d
Cleared Apr 04, 2006
NOVABONE POROUS-BONE GRAFT SCAFFOLD
K060432 · MQV
Novabone Products, LLC
Orthopedic · 42d
Cleared Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
K060655 · DQY
Biotronik, Inc.
Cardiovascular · 22d
Cleared Apr 04, 2006
PMP4 BP PRO BLOOD PRESSURE MONITOR
K060703 · DXN
Card Guard Scientific Survival , Ltd.
Cardiovascular · 19d
Cleared Apr 04, 2006
XPERCT
K060749 · IZI
Philips Medical Systems North America...
Radiology · 15d
Cleared Apr 03, 2006
DOSE VERIFICATION SYSTEM
K052118 · LHN
Sicel Technologies, Inc.
Radiology · 242d
Cleared Apr 03, 2006
ARTHREX ARTHOERESIS IMPLANT
K053543 · HWC
Arthrex, Inc.
Orthopedic · 104d
Cleared Apr 03, 2006
INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS
K060014 · JDR
Intelifuse, Inc.
Orthopedic · 90d
Cleared Mar 31, 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 416d
Cleared Mar 31, 2006
MAXILIM
K052424 · LLZ
Medicim NV
Radiology · 210d
Cleared Mar 31, 2006
SIROENDO
K052515 · EKX
Sirona Dental Systems GmbH
Dental · 198d
Cleared Mar 31, 2006
ETI-MAX 3000
K052794 · JJF
DiaSorin, Inc.
Immunology · 179d
Cleared Mar 31, 2006
RX IMOLA
K052914 · CEM
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Mar 31, 2006
AGILITY LP TOTAL ANKLE PROSTHESIS
K053569 · HSN
DePuy Orthopaedics, Inc.
Orthopedic · 99d
Cleared Mar 31, 2006
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
K053583 · HIH
Optivia Medical, LLC
Obstetrics & Gynecology · 98d
Cleared Mar 31, 2006
TIANJIN MEDIS DISPOSABLE INFUSION SET
K060082 · FPA
Tianjin Medis International Trade...
General Hospital · 80d
Cleared Mar 31, 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · EGJ
Iomed, Inc.
Physical Medicine · 60d
Cleared Mar 31, 2006
E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND...
K060255 · GEI
E Surgical, LLC
General & Plastic Surgery · 58d
Cleared Mar 31, 2006
ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
K060269 · FBN
Acmi Corporation
Gastroenterology & Urology · 58d
Cleared Mar 31, 2006
NXSTAGE DIALYSATE PREPARATION MODULE
K060296 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 53d
Cleared Mar 31, 2006
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
K060542 · IYN
General Electric Co.
Radiology · 30d
Cleared Mar 31, 2006
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
K060550 · KPR
Eastman Kodak Company
Radiology · 29d