FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128089–128112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1990
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190 · DHB
Pharmacia, Inc.
Immunology · 220d
Cleared Jan 22, 1990
MESAM RECORDER
K894641 · BZQ
Madaus Medtec, Inc.
Anesthesiology · 182d
Cleared Jan 22, 1990
VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM
K894695 · GCX
Medistad Corp.
General Hospital · 182d
Cleared Jan 22, 1990
PROTOLOGIC MODEL SER-1
K894936 · BZE
Protologic, Inc.
Anesthesiology · 172d
Cleared Jan 22, 1990
THE OPTIC BOX CONTACT LENS CASE
K895167 · LRX
The Optic Box Co., Ltd.
Ophthalmic · 153d
Cleared Jan 22, 1990
MODEL EB-22 NOISE STIK
K895200 · EWO
Eckstein Brothers, Inc.
Ear, Nose, Throat · 157d
Cleared Jan 22, 1990
TYPE FP40 DIGITAL HEARING AID ANALYZER
K895383 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 145d
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K895617 · LYY
Lit Seng Development Sdn. Bhd.
General Hospital · 125d
Cleared Jan 22, 1990
ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
K895800 · HQR
Advanced Surgical Products, Inc.
Ophthalmic · 116d
Cleared Jan 22, 1990
PHOENIX
K895855 · KNS
Medical and Scientific Enterprises, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 22, 1990
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
K896024 · EAP
Mdt Diagnostic Co.
Radiology · 98d
Cleared Jan 22, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
K896124 · IYT
Medipart Jerry Alexander
Radiology · 91d
Cleared Jan 22, 1990
DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
K896157 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
K896158 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
K896159 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
ASC-954 INTEGRATOR AMPLIFIER
K896164 · GWK
Astro-Med, Inc.
Neurology · 90d
Cleared Jan 22, 1990
HERRICK LACRIMAL PLUG TM.
K896175 · LZU
Lacrimedics, Inc.
Ophthalmic · 89d
Cleared Jan 22, 1990
SAFE-T-CAP NEEDLE COVER
K896219 · DZM
Ausmedics Pty , Ltd.
Dental · 87d
Cleared Jan 22, 1990
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K896315 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 82d
Cleared Jan 22, 1990
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · CAI
Baxter Healthcare Corp
Anesthesiology · 77d
Cleared Jan 22, 1990
PORGES NASOBILIARY DRAIN
K896376 · FGE
Porges Corp.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
URETERAL ACCESS SET
K896385 · KOD
Applied Urology, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
PORGES BILIARY STENTS
K896423 · FGE
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
PORGES SPHINCTEROTOMES
K896426 · KNS
Porges Corp.
Gastroenterology & Urology · 75d