FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78337–78360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2001
CERCON CERAM
K011333 · EIH
Degussa - Ney Dental, Inc.
Dental · 110d
Cleared Aug 20, 2001
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
K011339 · DSI
Spacelabs Burdick, Inc.
Cardiovascular · 110d
Cleared Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053 · MID
Diamedix Corp.
Immunology · 49d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · CHL
Nova Biomedical Corp.
Chemistry · 49d
Cleared Aug 20, 2001
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
K012117 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
K012118 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
K012119 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
K012120 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122 · JJX
Maine Standards Co.
Chemistry · 45d
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