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
72193–72216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2003
AIGIS-SOFT
K024136 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
AIGIS-SUPER
K024142 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
AIGIS-FINE
K024143 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
STRYKERWARE SYSTEM
K024159 · LLZ
Stryker Endoscopy
Radiology · 83d
Cleared Mar 10, 2003
RMO PLASMA CURING LIGHT
K024374 · EBZ
Lokki Lasers Medicaux
Dental · 69d
Cleared Mar 10, 2003
ATAC PAK MAGNESIUM REAGENT
K030010 · JGJ
Elan Diagnostics
Chemistry · 67d
Cleared Mar 10, 2003
FYRELINK
K030242 · LLZ
Mpacs, LLC
Radiology · 46d
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · FGE
Cordis Corp.
Gastroenterology & Urology · 31d
Cleared Mar 10, 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · JAK
GE Medical Systems
Radiology · 28d
Cleared Mar 10, 2003
AMERICAN CATHETER, MODEL W3
K030538 · EZD
Catheter, LLC
Gastroenterology & Urology · 18d
Cleared Mar 07, 2003
IM2001 PULSE OXIMETER
K012706 · DQA
Imagyn Medical Technologies, Inc.
Anesthesiology · 570d
Cleared Mar 07, 2003
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
K022167 · CAC
Pall Corp.
Anesthesiology · 247d
Cleared Mar 07, 2003
TRUEZONE PEAK FLOW METER
K023097 · BZH
Monaghan Medical Corp.
Anesthesiology · 170d
Cleared Mar 07, 2003
XYLOS XCELL ANTIMICROBIAL DRESSING
K024054 · MGQ
Xylos Corporation
General & Plastic Surgery · 88d
Cleared Mar 07, 2003
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
K024061 · GEX
Peregrine Surgical , Ltd.
General & Plastic Surgery · 88d
Cleared Mar 07, 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · JOW
Alliance Medical Corp.
Cardiovascular · 87d
Cleared Mar 07, 2003
NAUTICA MICRO CATHETER, MODEL 105-5094-153
K024122 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 81d
Cleared Mar 07, 2003
AIGIS-INLAY
K024139 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
AIGIS-PT
K024144 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
AIGIS-XO
K024145 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
VIATORR ENDOPROSTHESIS
K024178 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 79d
Cleared Mar 07, 2003
AUDIOSCREENER OAE+ABR
K024205 · EWO
Everest Biomedical Instruments Co.
Ear, Nose, Throat · 77d
Cleared Mar 07, 2003
ATAC PAK ALBUMIN REAGENT
K030006 · CIX
Elan Diagnostics
Chemistry · 64d
Cleared Mar 07, 2003
ATAC PAK PHOSPHORUS REAGENT
K030015 · CEO
Elan Diagnostics
Chemistry · 64d