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

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176,076 results
54169–54192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 133d
Cleared Mar 04, 2009
DATACOM DC PACS
K083182 · LLZ
Datacom Technology Corp.
Radiology · 127d
Cleared Mar 04, 2009
INCLUSIVE TITANIUM ABUTMENT BLANKS
K083192 · NHA
Inclusive Dental Solutions
Dental · 126d
Cleared Mar 04, 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311 · ODP
Aesculap Implant Systems, Inc.
Orthopedic · 114d
Cleared Mar 04, 2009
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL...
K083357 · OMP
Kci USA, Inc.
General & Plastic Surgery · 111d
Cleared Mar 04, 2009
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
K083451 · BSN
Smiths Medical Asd, Inc.
Anesthesiology · 103d
Cleared Mar 04, 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573 · HRS
Synthes (Usa)
Orthopedic · 91d
Cleared Mar 04, 2009
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
K083607 · HWC
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
K083612 · HWC
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
K083791 · FPD
Corpak Medsystems
Gastroenterology & Urology · 75d
Cleared Mar 04, 2009
BIPAP AUTOSV
K090248 · MNS
Respironics Inc., Sleep & Home...
Anesthesiology · 30d
Cleared Mar 04, 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252 · KWP
Lanx, Inc.
Orthopedic · 30d
Cleared Mar 04, 2009
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
K090281 · GEX
Accutech Medical Technologies, Inc.
General & Plastic Surgery · 27d
Cleared Mar 04, 2009
BODYVIZ, MODEL 100
K090295 · LLZ
Visual Medical Solutions, LLC
Radiology · 27d
Cleared Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K090348 · JXG
Codman & Shurtleff, Inc.
Neurology · 21d
Cleared Mar 03, 2009
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
K083471 · OTN
Generic Medical Device, Inc.
Gastroenterology & Urology · 99d
Cleared Mar 03, 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · MMK
Industrial Water Solutions, Inc.
General Hospital · 97d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · KWZ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Mar 03, 2009
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
K083788 · EYB
Endooptiks, Inc.
Gastroenterology & Urology · 74d
Cleared Mar 03, 2009
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K090274 · DQX
Micrus Endovascular Corporation
Cardiovascular · 27d
Cleared Mar 02, 2009
NEOSS ACCESS ABUTMENTS
K081851 · NHA
Neoss, Ltd.
Dental · 245d
Cleared Mar 02, 2009
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · GEH
AtriCure, Inc.
General & Plastic Surgery · 222d
Cleared Mar 02, 2009
THE PFT FILTER
K083233 · BZG
Pulmonary Filtration Technologies, LLC
Anesthesiology · 119d
Cleared Mar 02, 2009
RADIONICS XKNIFE HDRT SYSTEM
K083414 · MUJ
Integra Radionics, Inc.
Radiology · 104d