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
49801–49824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2010
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA,...
K101298 · OCZ
Endochoice, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 04, 2010
ICAD VERALOOK CTC CAD SOFTWARE
K091529 · JAK
Icad, Inc.
Radiology · 439d
Cleared Aug 04, 2010
ORTHOMAP 3D 1.1 MODULE
K093206 · OLO
Stryker Corp.
Orthopedic · 295d
Cleared Aug 04, 2010
CONTRALCO
K100879 · DJZ
Contralco
Toxicology · 127d
Cleared Aug 04, 2010
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
K101198 · DXN
Computerized Screening, Inc.
Cardiovascular · 97d
Cleared Aug 04, 2010
CORRIDOR4DM V2010 MODEL: V2010
K101279 · LLZ
Invia
Radiology · 90d
Cleared Aug 04, 2010
REEFLEX PTA CATHETER
K101361 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 82d
Cleared Aug 04, 2010
SCANDIA-45 GAMMA CAMERA SYSTEM
K101391 · IYX
Scandia Corporation
Radiology · 78d
Cleared Aug 04, 2010
DUSIMETRY CHECK
K101503 · IYE
Math Resolutions, LLC
Radiology · 64d
Cleared Aug 04, 2010
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL...
K101747 · FLL
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 43d
Cleared Aug 04, 2010
NEOTRACT ANCHOR SYSTEM MODEL TAS400
K102028 · GAT
Neotract, Inc.
General & Plastic Surgery · 16d
Cleared Aug 03, 2010
ALIGN RADIAL HEAD SYSTEM
K092721 · KWI
Skeletal Dynamics, LLC
Orthopedic · 333d
Cleared Aug 03, 2010
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
K092892 · DWL
I-Ming Sanitary Materials Co., Ltd.
General Hospital · 316d
Cleared Aug 03, 2010
NEOMED ENTERAL ONLY EXTENSION SET
K100288 · KNT
Neomed, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 03, 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · HRS
Synthes (Usa)
Orthopedic · 138d
Cleared Aug 03, 2010
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
K100966 · FDF
Sheathing Technologies, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 03, 2010
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE)...
K101180 · FPA
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Aug 03, 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q,...
K101289 · MQB
Air Techniques, Inc.
Radiology · 88d
Cleared Aug 03, 2010
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
K101387 · FLL
Fudakang Industries Co., Ltd.
General Hospital · 77d
Cleared Aug 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
K091303 · JPK
Bio-Rad Laboratories
Hematology · 455d
Cleared Aug 02, 2010
STA-HYBRID HEP CALIBRATOR
K092937 · JIT
Diagnostica Stago, Inc.
Hematology · 312d
Cleared Aug 02, 2010
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL...
K093079 · KNS
Hobbs Medical, Inc.
Gastroenterology & Urology · 306d
Cleared Aug 02, 2010
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · LDP
Siemens Healthcare Diagnostics
Toxicology · 189d
Cleared Aug 02, 2010
ASCENSION TOTAL PLATE SYSTEM
K100502 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 161d