FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79465–79488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 30, 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD...
K010835 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 41d
Cleared Apr 30, 2001
SIMPLICITY WING INFUSION SET
K010886 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 27, 2001
SENOJ IMPLANT SYSTEM
K000889 · DZE
Senoj Biocare, Inc.
Dental · 403d
Cleared Apr 27, 2001
GRAFT MARKER RING
K001915 · MAB
T. Korossurgical Instruments Corp.
Cardiovascular · 308d
Cleared Apr 27, 2001
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
K003325 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 185d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · HRX
Aesculap, Inc.
Orthopedic · 144d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · LTZ
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 98d