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

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175,820 results
51433–51456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2009
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 110d
Cleared Dec 30, 2009
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · FRC
STERIS Corporation
General Hospital · 100d
Cleared Dec 30, 2009
FONIX ,MODEL 8000
K093006 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 93d
Cleared Dec 30, 2009
BANTAM,48XXXXXX, 50XXXXXX
K093139 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 86d
Cleared Dec 29, 2009
PIEZOSURGERY 3
K091227 · DZI
Piezosurgery S.R.L.
Dental · 245d
Cleared Dec 29, 2009
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
K091585 · OMP
Kci USA, Inc.
General & Plastic Surgery · 210d
Cleared Dec 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911,...
K092588 · DXN
Andon Health Co, Ltd.
Cardiovascular · 127d
Cleared Dec 29, 2009
MILTEX MEMBRANE TACK KIT
K092855 · DZL
Miltex, Inc.
Dental · 104d
Cleared Dec 29, 2009
SYNTHES MATRIX SYSTEM
K092929 · NKB
Synthes (Usa)
Orthopedic · 97d
Cleared Dec 29, 2009
LIPOSE DISPOSABLE CANNULA
K093067 · QPB
Lipose Corp.
General & Plastic Surgery · 90d
Cleared Dec 29, 2009
MARS HOLTER ANALYSIS WORKSTATION
K093141 · DQK
Ge Medical Systems Information...
Cardiovascular · 85d
Cleared Dec 28, 2009
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH...
K091851 · LZA
Gx Corporation Sdn Bhd
General Hospital · 189d
Cleared Dec 28, 2009
HUMAN IGD KIT FOR USE ON SPAPLUS
K092450 · CZJ
The Binding Site
Immunology · 140d
Cleared Dec 28, 2009
SIMPLER TOADSTOOL MINI IMPLANT
K092674 · DZE
Pan Global Implant
Dental · 118d
Cleared Dec 28, 2009
PENTEX EC-3890LI
K093037 · FDF
Pentax Medical Company
Gastroenterology & Urology · 90d
Cleared Dec 28, 2009
STARCARE HANDPIECE MAINTENANCE UNIT
K093072 · EFB
Dentalez, Inc.
Dental · 89d
Cleared Dec 24, 2009
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
K090959 · KZE
D'Antonio Consultants International,...
General Hospital · 262d
Cleared Dec 24, 2009
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
K093035 · NBW
Taidoc Technology Corporation
Chemistry · 85d
Cleared Dec 24, 2009
PROTON THERAPY MULTILEAF COLLIMATOR
K093250 · LHN
Varian Medical Systems
Radiology · 69d
Cleared Dec 24, 2009
LIFEDOP MODEL 300ABI
K093393 · JAF
Summit Doppler Systems, Inc.
Radiology · 55d
Cleared Dec 24, 2009
PARADIS VASO SHIELD
K093551 · OMR
Spinemedica, LLC
Cardiovascular · 37d
Cleared Dec 23, 2009
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
K090534 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 299d
Cleared Dec 23, 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555 · DTR
Maquet Cardiopulmonary, AG
Cardiovascular · 296d
Cleared Dec 23, 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K090690 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 282d