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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
43201–43224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2012
ARTHREX SUTURE (UHMWPE)
K122374 · GAT
Arthrex, Inc.
General & Plastic Surgery · 50d
Cleared Sep 25, 2012
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
K122428 · MWP
Faxitron Bioptics, LLC
Radiology · 47d
Cleared Sep 25, 2012
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K122638 · MOS
Quality Electrodynamics
Radiology · 27d
Cleared Sep 24, 2012
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · LCX
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 396d
Cleared Sep 24, 2012
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
K113836 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 271d
Cleared Sep 24, 2012
THE PL-1064 LASER SYSTEM
K120938 · PDZ
Sheaumann Laser, Inc.
General & Plastic Surgery · 186d
Cleared Sep 24, 2012
INOMAX DS (DELIVERY SYSTEM)
K121021 · MRN
Ino Therapeutics
Anesthesiology · 173d
Cleared Sep 24, 2012
GEMINI LITHOTRIPTER
K121656 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 111d
Cleared Sep 24, 2012
LEW MDI O-BALL COLLARED IMPLANT,
K121707 · DZE
Park Dental Research Corp.
Dental · 105d
Cleared Sep 24, 2012
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259 · DXQ
Hangzhou Reli-On Co., Ltd.
Cardiovascular · 59d
Cleared Sep 21, 2012
ECHOSOFT(TM)
K111142 · LLZ
Echometrix, LLC
Radiology · 518d
Cleared Sep 21, 2012
HUMID-VENT HEPA
K112958 · CAH
Teleflex Medical
General Hospital · 352d
Cleared Sep 21, 2012
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP...
K120943 · MBI
ArthroCare Corporation
Orthopedic · 176d
Cleared Sep 21, 2012
ADIPREP ADIPOSE TRANSFER SYSTEM
K121005 · MUU
Harvest Technologies, Corp.
General & Plastic Surgery · 171d
Cleared Sep 21, 2012
ALMA LASERS FAMILY OF PIXEL RF TIPS
K121150 · GEI
Alma Lasers, Inc.
General & Plastic Surgery · 158d
Cleared Sep 21, 2012
TROOPER OXYGEN CONCENTRATOR
K121260 · CAW
Vbox, Inc.
Anesthesiology · 148d
Cleared Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
K121558 · DCK
Diazyme Laboratories
Chemistry · 115d
Cleared Sep 21, 2012
DALI SPINAL FIXATION SYSTEM
K121568 · NKB
Accel Spine
Orthopedic · 115d
Cleared Sep 21, 2012
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
K121589 · JEY
Biomet Microfixation
Dental · 113d
Cleared Sep 21, 2012
ASPIRE HD PLUS, ASPIRE HD-S
K121674 · MUE
Fujifilm Medical System U.S.A., Inc.
Radiology · 107d
Cleared Sep 21, 2012
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · GXI
Biomerics
Neurology · 95d
Cleared Sep 21, 2012
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM...
K121848 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 21, 2012
PRISM ACQUIRE PRISM PROCESS PRISM VIEW
K122026 · LNH
Prism Clinical Imaging, Inc.
Radiology · 72d
Cleared Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 67d