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
74977–75000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S,...
K022099 · FOZ
Hdc Corp.
General Hospital · 85d
Cleared Sep 20, 2002
PRECISEPLAN 2.0
K022411 · MUJ
Precision Therapy Intl., Inc.
Radiology · 58d
Cleared Sep 20, 2002
SOAKER CATHETER
K022869 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Sep 20, 2002
POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
K022912 · DZE
Basic Dental Implant Systems, Inc.
Dental · 17d
Cleared Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021646 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021649 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
MY ALLERGY TEST
K021698 · JKA
Immunetech Corporation
Immunology · 120d
Cleared Sep 19, 2002
DISPOSABLE TEMPORARY PACING CABLE,MODELS...
K022075 · DSA
Cp Medical
Cardiovascular · 85d
Cleared Sep 19, 2002
3I DENTAL IMPLANT ACCESSORIES
K022113 · DZE
Implant Innovations, Inc.
Dental · 83d
Cleared Sep 19, 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · CBK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 80d
Cleared Sep 19, 2002
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
K022196 · LBI
Natus Medical, Inc.
General Hospital · 76d
Cleared Sep 19, 2002
STERNGOLD 1, MODEL 1127781
K022252 · EJS
Sterngold
Dental · 69d
Cleared Sep 19, 2002
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K022318 · HIF
Vomed Volzer Medizintechnik GmbH & Co.
Obstetrics & Gynecology · 73d
Cleared Sep 19, 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · KRH
St. Jude Medical, Inc.
Cardiovascular · 59d
Cleared Sep 19, 2002
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC...
K022387 · LLI
Craftmatic Organization, Inc.
General Hospital · 58d
Cleared Sep 19, 2002
DVT60
K022786 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 28d
Cleared Sep 19, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 27d
Cleared Sep 19, 2002
PUMP TUBING WITH X-COATING
K022857 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 22d
Cleared Sep 19, 2002
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · DZE
Straumann USA
Dental · 22d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 19, 2002
GE QUASAR NUCLEAR MEDICINE SYSTEM
K022960 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 13d
Cleared Sep 18, 2002
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
K013280 · MED
Sterilox Technologies, Inc.
General Hospital · 351d
Cleared Sep 18, 2002
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
K020255 · ODA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 237d
Cleared Sep 18, 2002
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
K020581 · KKX
Medical Concepts Development, Inc.
General Hospital · 209d