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
90457–90480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1998
RANDOX CALCIUM
K974607 · CJY
Randox Laboratories, Ltd.
Chemistry · 54d
Cleared Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
K980028 · CKA
Trace America, Inc.
Chemistry · 28d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · MBI
Mitek Products
Orthopedic · 381d
Cleared Jan 30, 1998
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK...
K970445 · MHX
Pace Tech Medical Monitors, Inc.
Cardiovascular · 359d
Cleared Jan 30, 1998
PHILIPS EASYVISION
K971965 · LLZ
Philips Medical Systems, Inc.
Radiology · 247d
Cleared Jan 30, 1998
EXCEL AV STIM 1000
K972157 · GWJ
Excel Tech. , Ltd.
Neurology · 235d
Cleared Jan 30, 1998
ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
K972298 · GCJ
The Altomec Corp.
General & Plastic Surgery · 225d
Cleared Jan 30, 1998
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
K973499 · HRX
Xomed, Inc.
Orthopedic · 136d
Cleared Jan 30, 1998
UROSURGE UROSTENT
K973504 · FAD
Princeton Regulatory Assoc.
Gastroenterology & Urology · 136d
Cleared Jan 30, 1998
CAPIOX HEMOCONCENTRATOR
K973516 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 135d
Cleared Jan 30, 1998
SOMNUS TISSUE COAGULATING ELECTRODE
K973701 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 123d
Cleared Jan 30, 1998
TRUMP-IT II AND MAGNUM 250
K973814 · GCJ
Valley West, Inc.
General & Plastic Surgery · 115d
Cleared Jan 30, 1998
IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS...
K974126 · DZE
Imcor
Dental · 88d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136 · MBI
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 30, 1998
UROMED NEEDLE GRASPER
K974137 · OCW
Uromed Corp.
Gastroenterology & Urology · 88d
Cleared Jan 30, 1998
ROCKET ELECTRODE
K974138 · HGI
A & A Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Jan 30, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M...
K974279 · GEI
3M Healthcare
General & Plastic Surgery · 77d
Cleared Jan 30, 1998
INFANT FLOW SYSTEM
K974303 · BZD
Sensor Medics Corp.
Anesthesiology · 74d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309 · HRS
Biomet, Inc.
Orthopedic · 74d
Cleared Jan 30, 1998
ADVANCE TOTAL KNEE SYSTEM
K974328 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 30, 1998
KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
K974391 · GCJ
Karl Storz Imaging, Inc.
General & Plastic Surgery · 70d
Cleared Jan 30, 1998
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM
K974392 · DZL
Biovision GmbH
Dental · 70d
Cleared Jan 30, 1998
IBI
K974440 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 66d
Cleared Jan 30, 1998
COMPOGLASS FLOW
K974577 · EBF
Ivoclar North America, Inc.
Dental · 53d