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
109273–109296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1994
GAMBRO BICART 720G
K940601 · KPO
C.G.H. Medical, Inc.
Gastroenterology & Urology · 40d
Cleared Mar 22, 1994
WALL IV EXTENSION TUBE
K940689 · FPA
Walla Medical Systems, Inc.
General Hospital · 34d
Cleared Mar 22, 1994
SILFREE 79
K940747 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared Mar 21, 1994
FLUSHING IRRIGATION SET
K923497 · KDH
Orion Life Systems, Inc.
Gastroenterology & Urology · 614d
Cleared Mar 21, 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K926544 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 445d
Cleared Mar 21, 1994
FLASH DENT
K931300 · EHD
Chicago X-Ray Systems, Inc.
Radiology · 371d
Cleared Mar 21, 1994
POROCOAT POROUS COATING
K931641 · LPH
Depuy, Inc.
Orthopedic · 353d
Cleared Mar 21, 1994
ACUFEX METAL ACL CANNULA
K932718 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 290d
Cleared Mar 21, 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR,...
K933731 · DTB
Medtronic Vascular
Cardiovascular · 231d
Cleared Mar 21, 1994
RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED
K933759 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 243d
Cleared Mar 21, 1994
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT
K933930 · BYJ
Puritan Bennett Corp.
Anesthesiology · 222d
Cleared Mar 21, 1994
KODAK EKTACHEM DT SLIDES (URCR)
K934071 · CGX
Eastman Kodak Company
Chemistry · 213d
Cleared Mar 21, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
K934273 · DMT
Eastman Kodak Company
Toxicology · 202d
Cleared Mar 21, 1994
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
K934350 · IXW
Eastman Kodak Company
Radiology · 195d
Cleared Mar 21, 1994
KODAK EKTACHEM DT SLIDES (FE)
K934358 · JQE
Eastman Kodak Company
Chemistry · 194d
Cleared Mar 21, 1994
SDR (SOFT DISSECTOR RAKE)
K935109 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 147d
Cleared Mar 21, 1994
STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
K935237 · GEI
Stryker Endoscopy
General & Plastic Surgery · 140d
Cleared Mar 21, 1994
FAST SPIN ECHO (FSE)
K935369 · LNH
Resonex, Inc.
Radiology · 137d
Cleared Mar 21, 1994
SALIVA EJECTOR DISPOSABLE
K935616 · DYN
Asa Instruments S.R.L.
Dental · 119d
Cleared Mar 21, 1994
HYGOFLEX SALIVA-EJECTOR
K935758 · DYN
J.H.Orsing AB
Dental · 115d
Cleared Mar 21, 1994
AIR CONDUCTION HEARING AID: IKON PP
K936106 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 89d
Cleared Mar 21, 1994
RIONET HEARING AID HB-53CI
K936122 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 88d
Cleared Mar 21, 1994
MIRACLE-EAR CONFIDANTE
K940458 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 48d
Cleared Mar 21, 1994
AUTO LUBE SYSTEM
K940535 · GEY
The Anspach Effort, Inc.
General & Plastic Surgery · 42d