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
77833–77856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2001
POLYTITER SYSTEM
K012163 · DHN
Polymedco, Inc.
Immunology · 40d
Cleared Aug 20, 2001
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
K012243 · JJY
Hematronix, Inc.
Chemistry · 34d
Cleared Aug 20, 2001
TEMP 3
K012276 · LGZ
Medical Solutions, Inc.
General Hospital · 32d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
K012291 · CFN
The Binding Site, Ltd.
Immunology · 31d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
K012295 · CFN
The Binding Site, Ltd.
Immunology · 31d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · LCD
Diagnostic Products Corp.
Chemistry · 28d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · KLB
Diagnostic Products Corp.
Toxicology · 28d
Cleared Aug 20, 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 19d
Cleared Aug 20, 2001
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
K012478 · CHL
I-Stat Corp.
Chemistry · 18d
Cleared Aug 17, 2001
ITI DENTAL IMPLANT SYSTEM
K003552 · DZE
Institut Straumann SA
Dental · 273d
Cleared Aug 17, 2001
SPEEDYBELL
K010735 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 158d
Cleared Aug 17, 2001
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
K011575 · KNW
Imagyn Surgical
Gastroenterology & Urology · 87d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280 · HWC
Triage Medical, Inc.
Orthopedic · 29d
Cleared Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · DXQ
Welch Allyn, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
GSIBP BLOOD PRESSURE CUFF
K012553 · DXQ
Globalshop, Inc.
Cardiovascular · 9d
Cleared Aug 16, 2001
VERTEX SEALAND L/C ORTHODONTIC SEALANT
K010547 · KLE
Apex Dental Materials, Inc.
Dental · 174d
Cleared Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
K010796 · MOI
Tosoh Medics, Inc.
Immunology · 153d
Cleared Aug 16, 2001
AQUASENS FLUID MONITORING SYSTEM
K011069 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 16, 2001
HELIOSEAL CLEAR CHROMA
K011491 · EBC
Ivoclar North America, Inc.
Dental · 93d
Cleared Aug 16, 2001
INFANT OXYGEN TREATMENT HOOD
K011565 · CBF
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 87d
Cleared Aug 16, 2001
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K011667 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 78d
Cleared Aug 16, 2001
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 70d