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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153001–153024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1984
NEURO SPONGE
K840541 · GDY
Surgicot, Inc.
General & Plastic Surgery · 75d
Cleared Apr 23, 1984
SURG-A-STAT FINE TIP 2
K840585 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 75d
Cleared Apr 23, 1984
LINEAR SCANNER 640
K840667 · IYO
Ge Medical Systems Information...
Radiology · 66d
Cleared Apr 23, 1984
FPP ARMBOARD STRAP
K840684 · FWZ
Fpp, Inc.
General & Plastic Surgery · 68d
Cleared Apr 23, 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · FRO
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 61d
Cleared Apr 23, 1984
JANACEK TUBO-UTERINE IMPLANTATION SET
K840766 · HTD
Cimed Intl., Inc.
General & Plastic Surgery · 60d
Cleared Apr 23, 1984
STRAITH DRAIN INSERTER
K840835 · FZX
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 59d
Cleared Apr 23, 1984
SD PLUS PATIENT CAT.#78-8010
K840963 · GZJ
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Apr 23, 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · GZJ
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Apr 23, 1984
CO2 LAPAROSCOPE
K841668
Laser Spectrum, Inc.
Gastroenterology & Urology
Cleared Apr 23, 1984
UTERINE MANIPULATOR 4.5MM
K841681
Humi Corp.
Obstetrics & Gynecology
Cleared Apr 20, 1984
DEAE-DEXTRAN IN PBS
K834116 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 143d
Cleared Apr 20, 1984
ULTRASOUND SCAN HEAD 3.5 MHZ
K834141 · IYO
Adr Ultrasound
Radiology · 121d
Cleared Apr 20, 1984
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
K834335 · LBI
Egnell, Inc.
General Hospital · 130d
Cleared Apr 20, 1984
CHEMLYTE
K834395 · FKQ
Diachem Laboratories
Gastroenterology & Urology · 128d
Cleared Apr 20, 1984
DRAINAGE STENT
K834468 · FGE
Microvasive
Gastroenterology & Urology · 122d
Cleared Apr 20, 1984
REAL FIBER OPTIC URETERAL TRANSILLUMIN
K834576 · FFS
Douglas Manufacturer Co.
Gastroenterology & Urology · 113d
Cleared Apr 20, 1984
IV-FILTER
K840248 · FPB
Tri-Med, Inc.
General Hospital · 92d
Cleared Apr 20, 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · BSZ
Ohio Medical Products
Anesthesiology · 85d
Cleared Apr 20, 1984
HEMOCATH
K840415 · FIQ
Quinton, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 20, 1984
B2-MICRO CONTROL
K840601 · JZG
Pharmacia, Inc.
Chemistry · 70d
Cleared Apr 20, 1984
DSL-150
K840611 · IYO
Shimadzu Corp.
Radiology · 67d
Cleared Apr 20, 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 20, 1984
LCD DIGITAL THERMOMETER
K840696 · FLL
Ltd Commodities, Inc.
General Hospital · 64d