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
95041–95064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
K965109 · CHP
Boehringer Mannheim Corp.
Chemistry · 60d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR...
K965111 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 18, 1997
ALT/SGPT
K965134 · CKA
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 18, 1997
SAS SERUM/URINE HCG
K965250 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
SAS PREGNANCY STRIP
K965253 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
ADVANCED QUALITY PREGNANCY TEST
K970008 · LCX
Bionike, Inc.
Chemistry · 47d
Cleared Feb 18, 1997
UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
K970066 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 41d
Cleared Feb 18, 1997
THYROID CALIBRATOR
K970389 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 15d
Cleared Feb 14, 1997
VENTANA ANTI-CD4 PRIMARY ANTIBODY
K941604 · DEH
Ventana Medical Systems, Inc.
Immunology · 1050d
Cleared Feb 14, 1997
VENTANA ANTI-CD8 PRIMARY ANTIBODY
K941784 · DEH
Ventana Medical Systems, Inc.
Immunology · 1040d
Cleared Feb 14, 1997
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
K960640 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 368d
Cleared Feb 14, 1997
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
K960727 · HGX
Evenflo Co., Inc.
Obstetrics & Gynecology · 358d
Cleared Feb 14, 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · KRH
St. Jude Medical, Inc.
Cardiovascular · 319d
Cleared Feb 14, 1997
DSXL DIFFUSION SPIROMETER
K961252 · BTY
Inair , Ltd.
Anesthesiology · 319d
Cleared Feb 14, 1997
GRASEBY ANDERSEN'S, INTEGRITY S700
K963131 · BZG
Graseby Andersen
Anesthesiology · 186d
Cleared Feb 14, 1997
BALDUR VINYL POWDERED GLOVES
K963441 · LYZ
Hti Trading Group
General Hospital · 168d
Cleared Feb 14, 1997
TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
K963505 · HHP
Tenet Medical Engineering
Obstetrics & Gynecology · 164d
Cleared Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · FPA
Vygon Corp.
General Hospital · 134d
Cleared Feb 14, 1997
VASOVIEW BALLOON DISSECTION SYSTEM
K964171 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 119d
Cleared Feb 14, 1997
AMSEAL SURGICAL FACE MASK
K964358 · FXX
American Seal Co.
General Hospital · 105d
Cleared Feb 14, 1997
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K964543 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 93d
Cleared Feb 14, 1997
TRUSTEX COLA FLAVORD CONDOM
K964598 · HIS
Line One Laboratories
Obstetrics & Gynecology · 88d
Cleared Feb 14, 1997
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
K964599 · HIS
Line One Laboratories
Obstetrics & Gynecology · 88d
Cleared Feb 14, 1997
OASIS HUMIDIFIER
K964653 · BTT
Respironics, Inc.
Anesthesiology · 86d