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
80065–80088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2001
BIOUNIVERSAL PDF
K011022 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
D.SIGN 96
K011023 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
SIII ALARM AMPLIFIER
K011088 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007,...
K011115 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 20d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · JIT
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · DIO
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 01, 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED)...
K002718 · LYY
Tillotson Healthcare Corp.
General Hospital · 243d
Cleared May 01, 2001
SPHYGMOCOR MX MODEL SCOR-MX
K002742 · DSK
Pwv Medical Pty, Lt.
Cardiovascular · 242d
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · DDG
Roche Diagnostics Corp.
Immunology · 211d
Cleared May 01, 2001
WELCON STERILE WATER FOR DEVICE IRRIGATION
K003402 · JOL
Welcon, Inc.
General Hospital · 181d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared May 01, 2001
DRX 2000
K010292 · ITH
Axiom Worldwide, Inc.
Physical Medicine · 90d
Cleared May 01, 2001
COOLTOUCH VARIA ND:YAG LASER SYSTEM
K010316 · GEX
Cooltouch Corp.
General & Plastic Surgery · 88d
Cleared May 01, 2001
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING...
K010438 · KGO
Terang Nusa Sdn Bhd
General Hospital · 77d
Cleared May 01, 2001
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING...
K010439 · KGO
Terang Nusa Sdn Bhd
General Hospital · 78d
Cleared May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · JPA
Dade Behring, Inc.
Hematology · 70d
Cleared May 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVE
K011012 · LZA
Contract Latex Dippers Sdn Bhd
General Hospital · 27d
Cleared May 01, 2001
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
K011093 · MHX
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared May 01, 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Apr 30, 2001
COBE HC 700 MIDI HEMOCONCENTRATOR
K003023 · KDI
Hospal Industrie
Gastroenterology & Urology · 214d
Cleared Apr 30, 2001
VACUETTE SPEEDY QUICK-RELEASE HOLDER
K003812 · FMI
Greiner Vacuette North America, Inc.
General Hospital · 140d
Cleared Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 123d
Cleared Apr 30, 2001
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
K010365 · MNG
Personal Products Co.
Gastroenterology & Urology · 82d
Cleared Apr 30, 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · FMF
Interpore Cross Intl.
General Hospital · 52d