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
116041–116064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1992
MILES URINE CALCIUM METHOD
K923034 · CIC
Heraeus Kulzer, Inc.
Chemistry · 88d
Cleared Sep 15, 1992
MILES URINE GLUCOSE METHOD
K923040 · CFR
Heraeus Kulzer, Inc.
Chemistry · 88d
Cleared Sep 15, 1992
UROSKOP D1, UROSKOP D2, AND UROSKOP D3
K923049 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Sep 15, 1992
IQ IMMUNOCHEMISTRY SISTEM
K923060 · JJE
Becton Dickinson Advanced Diagnostics
Chemistry · 82d
Cleared Sep 15, 1992
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
K923285 · ECB
Smith & Nephew, Inc.
Dental · 71d
Cleared Sep 15, 1992
MICRO EIA FOR OPIATE METABOLITES
K923468 · DJG
Microdiagnostics, Inc.
Toxicology · 63d
Cleared Sep 15, 1992
CEDIA DIGOXIN PLUS ASSAY
K923853 · KXT
Microgenics Corp.
Toxicology · 50d
Cleared Sep 14, 1992
866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS
K914685 · DHB
In Vitro Technologies, Inc.
Immunology · 332d
Cleared Sep 14, 1992
BRINDLEY & SMITH ET-1000
K915100 · LIH
Zmi Corp.
Neurology · 307d
Cleared Sep 14, 1992
IGE EIA TEST KIT
K920087 · DGO
The Binding Site, Ltd.
Immunology · 250d
Cleared Sep 14, 1992
URESIL SUMP DRAINAGE CATHETER
K920509 · LJE
Uresil Corp.
Gastroenterology & Urology · 223d
Cleared Sep 14, 1992
URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER
K920510 · GAR
Uresil Corp.
General & Plastic Surgery · 225d
Cleared Sep 14, 1992
BENDEREV PROTECT-A-PASS NEEDLE
K921228 · KOA
Eimark Labs, Inc.
Gastroenterology & Urology · 185d
Cleared Sep 14, 1992
OPUS(R) TOXO-G TEST SYSTEM
K921523 · LGD
Pb Diagnostics, Inc.
Microbiology · 167d
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · LSE
Incstar Corp.
Microbiology · 161d
Cleared Sep 14, 1992
QD WHOLE BODY COIL, MRT-150A
K922798 · LNH
Toshiba America Mri, Inc.
Radiology · 96d
Cleared Sep 14, 1992
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922937 · EOQ
Optimed Technologies, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 14, 1992
KB40-KF
K922956 · EJS
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Sep 14, 1992
PARAGON
K922957 · EJS
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Sep 14, 1992
URESIL NEPHROSTOMY CATHETER
K923097 · LJE
Uresil Corp.
Gastroenterology & Urology · 81d
Cleared Sep 14, 1992
SKIN SUPPORT PREP PAD
K923351 · KOX
Coloplast Corp.
General & Plastic Surgery · 68d
Cleared Sep 14, 1992
THC URINE CALIBRATORS
K923386 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 75d
Cleared Sep 14, 1992
SINGLE DOSE GAS INJECTOR
K923397 · BXX
Escalon Medical Trek
Anesthesiology · 66d
Cleared Sep 11, 1992
CPA/3.5 MHZ PROBE
K911435 · ITX
Diasonics, Inc.
Radiology · 528d