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
94633–94656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1997
CANNULA
K965121 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 20, 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · BTR
Mallinckrodt Medical
Anesthesiology · 87d
Cleared Mar 20, 1997
SIMAR, INC. SURGICAL DRESSING
K970020 · EFQ
Simar, Inc.
General & Plastic Surgery · 76d
Cleared Mar 19, 1997
NEUROLOGICAL OR CRANI TRAYS (PACKS)
K932221 · LRO
Associated Medical Products Co.
General & Plastic Surgery · 1412d
Cleared Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728 · HLI
Mira, Inc.
Ophthalmic · 706d
Cleared Mar 19, 1997
AARON VAC 2
K952558 · HKP
Aaron Medical Industries
Ophthalmic · 656d
Cleared Mar 19, 1997
THE SWIRLER NEBULIZER
K952910 · CAF
Amici, Inc.
Anesthesiology · 632d
Cleared Mar 19, 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · IZH
Medical Marketing Intl., Inc.
Radiology · 579d
Cleared Mar 19, 1997
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
K953996 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 573d
Cleared Mar 19, 1997
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
K955461 · BTO
VBM Medizintechnik GmbH
Anesthesiology · 476d
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · DYF
Meadox Medicals, Div. Boston...
Cardiovascular · 387d
Cleared Mar 19, 1997
LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)
K960842 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 386d
Cleared Mar 19, 1997
SPINAL NEEDLES
K961151 · BSP
Hakko Shoji Co., Ltd.
Anesthesiology · 362d
Cleared Mar 19, 1997
TUOHY EPIDURAL NEEDLES
K961152 · BSP
Hakko Shoji Co., Ltd.
Anesthesiology · 362d
Cleared Mar 19, 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · DXT
B.Braun Medical, Inc.
Cardiovascular · 289d
Cleared Mar 19, 1997
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · BYE
Instrumentation Industries, Inc.
Anesthesiology · 205d
Cleared Mar 19, 1997
WALLACH INTEGRATION UNIT
K963348 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 205d
Cleared Mar 19, 1997
EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
K963507 · GZJ
Comtek Intl., Corp.
Neurology · 197d
Cleared Mar 19, 1997
PHILIPS SONO DIAGNOST 800
K963706 · IYO
Hewlett-Packard Co.
Radiology · 184d
Cleared Mar 19, 1997
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976 · DDG
Beckman Instruments, Inc.
Immunology · 166d
Cleared Mar 19, 1997
NARKOMED GS ANESTHESIA SYSTEM
K963994 · BSZ
Draeger Medical, Inc.
Anesthesiology · 166d
Cleared Mar 19, 1997
CRYOSIL SILICONE GEL SHEETING
K964047 · GEH
Biodermis Corp.
General & Plastic Surgery · 161d
Cleared Mar 19, 1997
CHASE TWO STAGE VENOUS RETURN CATHETER
K964195 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
CAHSE AORTIC ROOT CANNULA
K964198 · DWF
Chase Medical, Inc.
Cardiovascular · 149d