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
173977–174000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1977
MADDATHERM PARAFFIN BATH
K770170 · IMC
Techhnilab Instruments, Inc.
Physical Medicine · 3d
Cleared Jan 26, 1977
STOMA SHIELD ADAPTER
K760927 · EXE
Rudolfo T. Sanchez
Gastroenterology & Urology · 90d
Cleared Jan 26, 1977
CATHETER, UMBILICAL ARTERY
K760966 · FOS
Sherwood Medical Industries
General Hospital · 83d
Cleared Jan 26, 1977
TYCOS DIAGNOSTIC PENLIGHT
K760972 · KYT
Taylor Instrument Analytics Co.
General Hospital · 83d
Cleared Jan 26, 1977
SURGICAL LIGHT - CHALLENGE 22 SERIES
K761018 · FQP
Amsco Co.
General & Plastic Surgery · 77d
Cleared Jan 26, 1977
CRADLING SYSTEM
K761032 · FLE
Medin Corp.
General Hospital · 72d
Cleared Jan 26, 1977
NEONATAL RESUSCITATOR, SAMSON
K761065 · BTM
Dem Medical, Inc.
Anesthesiology · 69d
Cleared Jan 26, 1977
BARD URINE METER W/ BAG
K761083 · EXR
C.R. Bard, Inc.
Gastroenterology & Urology · 68d
Cleared Jan 26, 1977
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT
K761136 · CHH
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jan 26, 1977
FLUID DISPENSING SYSTEM
K761158 · FMF
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 58d
Cleared Jan 26, 1977
FLOUROMETER/DENSITOMETER MODEL 720
K770026 · JQT
Corning Medical & Scientific
Chemistry · 20d
Cleared Jan 26, 1977
LDH ISOTROL T
K770049 · JJT
Sigma Chemical Co.
Chemistry · 16d
Cleared Jan 26, 1977
GDH-GLUCOSE (RATE) REAGENT KIT
K770062
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Jan 26, 1977
BIO TROL-T TRIOLEIN SOLUTIONS
K770072 · JIS
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Jan 26, 1977
CARPENTER BONE CLAMP
K770118 · HXD
Stryker Corp.
General & Plastic Surgery · 5d
Cleared Jan 26, 1977
PROSTATE BIOPSY NEEDLE
K770122 · KNW
Cook, Inc.
Gastroenterology & Urology · 5d
Cleared Jan 26, 1977
PRE-ROLLED IMPERVIOUS STOCKINETTE
K770124
National Patent Development Corp.
Orthopedic · 5d
Cleared Jan 26, 1977
B.G. COMPRESSION SYSTEM
K770128 · HRS
Howmedica Corp.
Orthopedic · 5d
Cleared Jan 26, 1977
B.G. FLEXIBLE NAIL SYSTEM
K770130 · JDS
Howmedica Corp.
Orthopedic · 5d
Cleared Jan 26, 1977
LIGHTCAST II CASTING SYSTEM (MODIFIED)
K770133 · ITG
Solar Laboratories, Inc.
Physical Medicine · 5d
Cleared Jan 26, 1977
LIGHTCAST II STOCKINETTE
K770134 · ITG
Solar Laboratories, Inc.
Physical Medicine · 5d
Cleared Jan 26, 1977
MICROFENESTRATED HIP REPLACEMENT COMPON.
K770161 · JDG
Medishield, Inc.
Orthopedic · 2d
Cleared Jan 25, 1977
GLUCOSE ANALYZER 2
K761060 · CGA
Beckman Instruments, Inc.
Chemistry · 68d
Cleared Jan 25, 1977
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K761061 · CDS
Beckman Instruments, Inc.
Chemistry · 68d