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
72025–72048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2003
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
K031991 · KGI
Image Analysis, Inc.
Radiology · 33d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · MOS
GE Medical Systems
Radiology · 28d
Cleared Jul 30, 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058 · KTT
Alliance Medical Corp.
Orthopedic · 28d
Cleared Jul 30, 2003
AURORA
K032082 · LNH
Aurora Imaging Technology, Inc.
Radiology · 23d
Cleared Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · JJY
Roche Diagnostics Corp.
Chemistry · 23d
Cleared Jul 29, 2003
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
K031550 · DQK
Vivometrics, Inc.
Cardiovascular · 74d
Cleared Jul 29, 2003
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K031647 · JOJ
Getinge USA, Inc.
General Hospital · 63d
Cleared Jul 29, 2003
BENCO SPHERICAL
K031658 · EJJ
Southern Dental Industries, Inc.
Dental · 62d
Cleared Jul 29, 2003
MIX2VIAL TRANSFER DEVICE
K031861 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 43d
Cleared Jul 29, 2003
VIRTUOSAPH
K031891 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 46d
Cleared Jul 29, 2003
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
K032062 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 26d
Cleared Jul 28, 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · MGQ
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 209d
Cleared Jul 28, 2003
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K030170 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 192d
Cleared Jul 28, 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · DZE
Implant Innovations, Inc.
Dental · 80d
Cleared Jul 28, 2003
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · QPB
Biosculpture Technology, Inc.
General & Plastic Surgery · 40d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 32d
Cleared Jul 28, 2003
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50...
K032007 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 28d
Cleared Jul 25, 2003
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
K030221 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 185d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766 · JDI
Smith & Nephew, Inc.
Orthopedic · 136d
Cleared Jul 25, 2003
THYRO TEST
K030912 · JLW
Thryotec
Chemistry · 123d
Cleared Jul 25, 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962 · KGI
Ge Lunar Corp.
Radiology · 120d
Cleared Jul 25, 2003
ELI 200+ AUDICOR
K031182 · DPS
Mortara Instrument, Inc.
Cardiovascular · 101d
Cleared Jul 25, 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · DTK
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Jul 25, 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · FMF
American Syringe Company
General Hospital · 84d