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
165433–165456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1980
ANAEROBE BLOOD AGAR
K802397 · JSG
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Oct 23, 1980
MODEL 2500 PNEUMATIC PERCUSSOR
K802399 · BYI
Medical Equipment Development Co., Inc.
Anesthesiology · 21d
Cleared Oct 23, 1980
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
K802404 · DCF
Ortho Diagnostics, Inc.
Immunology · 17d
Cleared Oct 23, 1980
E-VAC BLOOD CULTURE SYSTEM
K802408 · JSC
Pfizer Pharmaceuticals
Microbiology · 20d
Cleared Oct 23, 1980
UMBILI-CATH CATHETER
K802414 · FOS
Int'L Corp.
General Hospital · 20d
Cleared Oct 23, 1980
SALEM/RESCE INTUBATION GUIDE
K802416 · BSR
Scientific Sales Intl., Inc.
Anesthesiology · 17d
Cleared Oct 23, 1980
AB O2 CONSUMPTION CALCULATOR 980
K802417 · BZL
Siemens Elema AB
Anesthesiology · 17d
Cleared Oct 23, 1980
UCG-BETA STAT
K802421 · JHJ
Armkel, LLC
Chemistry · 17d
Cleared Oct 23, 1980
RESPO2 OXYGEN CONCENTRATOR
K802426 · CAW
Mada Medical Products, Inc.
Anesthesiology · 17d
Cleared Oct 23, 1980
PROPPER SHARPGUARD & TRAYPAD STERIL. AID
K802428 · FRG
Propper Mfg. Co., Inc.
General Hospital · 17d
Cleared Oct 23, 1980
COTTON ROLLS
K802429 · EFN
Worldwide Surgical Gauze
Dental · 20d
Cleared Oct 23, 1980
NEBULIZER, MEDICINAL
K802430 · EPN
Dhd Medical Products Div. Diemolding...
Ear, Nose, Throat · 17d
Cleared Oct 23, 1980
UCG-BETA SLIDE
K802435 · JHJ
Armkel, LLC
Chemistry · 17d
Cleared Oct 23, 1980
ARGYLE COMPACT CHEST DRAINAGE SYS.
K802440 · GCX
Sherwood Medical Co.
General Hospital · 16d
Cleared Oct 23, 1980
E.R.C.P. CANNULA PRODUCT
K802443 · ODD
Mill-Rose Laboratory
Gastroenterology & Urology · 16d
Cleared Oct 23, 1980
PAPILLOTOME PRODUCT
K802444 · KNS
Mill-Rose Laboratory
Gastroenterology & Urology · 16d
Cleared Oct 23, 1980
SIEMENS-ELEMA AB CO2 MONITOR 130
K802459 · CCK
Siemens Elema AB
Anesthesiology · 15d
Cleared Oct 23, 1980
DAHLBERG HEARING AID MODEL AI
K802510 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 21, 1980
URETHRAL CATHETERIZATION TRAYS
K801785 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 21, 1980
URINARY CATHETER CARE TRAYS #3700&3710
K801787 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 21, 1980
FOLEY CATHETERIZATION TRAY
K801820 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 20, 1980
HEPA-SHURE -L
K802120 · JJK
Nuclear Medical Laboratories, Inc.
Hematology · 46d
Cleared Oct 20, 1980
EMIT-STM URINE CONTROLS
K802622
Syva Co.
Toxicology
Cleared Oct 17, 1980
REGIONAL INTRAVENOUS ANESTHESIA KIT
K802290 · CAZ
Stanco Medical, Inc.
Anesthesiology · 28d