FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103609–103632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1995
CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
K945977 · MGP
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 111d
Cleared Mar 29, 1995
CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
K946338 · MGP
Certified Safety Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Mar 29, 1995
INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER
K950277 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 65d
Cleared Mar 29, 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
K950414 · LLL
Hemagen Diagnostics, Inc.
Immunology · 57d
Cleared Mar 29, 1995
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS,...
K950434 · OCZ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 29, 1995
RICH-MAR CARBON ELECTRODES
K950491 · GXY
Rich-Mar Corp.
Neurology · 51d
Cleared Mar 29, 1995
SMART ANESTHESIA MULTI-GAS (SAM) MODULE
K950581 · CCK
Marquette Electronics, Inc.
Anesthesiology · 48d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K950737 · FOZ
Menlo Care, Inc.
General Hospital · 41d
Cleared Mar 29, 1995
ZEISS ENDOLIVE STERO ENDOSCOPE
K950985 · GCJ
Carl Zeiss, Inc.
General & Plastic Surgery · 26d
Cleared Mar 28, 1995
EDD
K924997 · BTR
Arc Medical, Inc.
Anesthesiology · 907d
Cleared Mar 28, 1995
RESOLUT REGENERATIVE MATERIAL
K932866 · LYC
W.L. Gore & Associates, Inc.
Dental · 652d
Cleared Mar 28, 1995
CLINICAL GLASS THERMOMETER
K942483 · FLK
Makol Medical Instruments Corp.
General Hospital · 307d
Cleared Mar 28, 1995
STATLOCK SECUREMENT DEVICES
K942931 · FPA
Venetec, Inc.
General Hospital · 279d
Cleared Mar 28, 1995
SPECTACLE FRAME
K944313 · HQZ
Sun Hing Optical Manufactory , Ltd.
Ophthalmic · 211d
Cleared Mar 28, 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE...
K944765 · KGE
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Mar 28, 1995
THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
K945656 · KKX
Micro-Medical Devices, Inc.
General Hospital · 131d
Cleared Mar 28, 1995
TDX(R)/TDXFLX(R) PHENYTOIN II
K946328 · LGR
Abbott Laboratories
Toxicology · 89d
Cleared Mar 28, 1995
MULTIPLE
K950083 · HQY
Commonwealth Optical Manufactory , Ltd.
Ophthalmic · 77d
Cleared Mar 28, 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO...
K950165 · LYC
Interpore Intl.
Dental · 70d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-1
K950789 · HKL
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3
K950791 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3A
K950792 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
SPOT RETINOSCOPE RX-3SP
K950793 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RC
K950794 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d