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
56425–56448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2008
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K073179 · CBK
Maquet Critical Care AB
Anesthesiology · 209d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD
Roche Diagnostics Corp.
Microbiology · 179d
Cleared Jun 09, 2008
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K080014 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Jun 09, 2008
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
K080175 · BSZ
Datascope Corp., Patient Monitoring...
Anesthesiology · 137d
Cleared Jun 09, 2008
NEB-U-MASK SYSTEM, MODELS 1895, 1896
K080230 · CAF
Teleflexmedical, Inc.
Anesthesiology · 131d
Cleared Jun 09, 2008
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
K080366 · DXQ
Zefon Intl.
Cardiovascular · 118d
Cleared Jun 09, 2008
MARTIN CHAIR, MODEL C4S1
K080506 · IOR
Martin Manufacturing Co., LLC
Physical Medicine · 105d
Cleared Jun 09, 2008
WG-SURGICAL SUTURES WITH NEEDLE
K080684 · GAP
Foosin Medical Supplies, Inc.
General & Plastic Surgery · 91d
Cleared Jun 09, 2008
CONNEXX LOCKING TIBIA NAIL
K080706 · JDS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 89d
Cleared Jun 09, 2008
THOR ANTERIOR PLATING SYSTEM
K080773 · KWQ
Stryker Spine
Orthopedic · 82d
Cleared Jun 09, 2008
MOSAIC LASER SYSTEM
K080932 · GEX
Lutronic Corporation
General & Plastic Surgery · 68d
Cleared Jun 09, 2008
PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
K081001 · NEW
Sutures India Pvt., Ltd.
General & Plastic Surgery · 62d
Cleared Jun 09, 2008
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
K081002 · GAM
Sutures India Pvt., Ltd.
General & Plastic Surgery · 62d
Cleared Jun 09, 2008
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
K081003 · GAM
Sutures India Pvt., Ltd.
General & Plastic Surgery · 62d
Cleared Jun 09, 2008
WATCH-PAT 200I (WP200I)
K081037 · MNR
Itamar Medical
Anesthesiology · 59d
Cleared Jun 09, 2008
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
K081318 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared Jun 06, 2008
NILIMEDIX ADI
K070844 · LZG
Nilimedix , Ltd.
General Hospital · 437d
Cleared Jun 06, 2008
X-VOID, SPIDER
K072198 · HRX
Sintea Biotech, Inc.
Orthopedic · 304d
Cleared Jun 06, 2008
NERVE MONITORING CABLE
K073229 · GXZ
Pioneer Surgical Technology
Neurology · 204d
Cleared Jun 06, 2008
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
K073712 · DWJ
Adroit Medical Systems, Inc.
Cardiovascular · 158d
Cleared Jun 06, 2008
ZIRKONDENT
K080146 · EIH
Ergometa
Dental · 136d
Cleared Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · NBC
Biosite Incorporated
Chemistry · 126d
Cleared Jun 06, 2008
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · NDY
The Binding Site, Ltd.
Chemistry · 114d
Cleared Jun 06, 2008
ERGO++ VERSION 1.7
K080601 · MUJ
3D Line Medical Systems S.R.L.
Radiology · 95d