Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78937–78960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2001
WECK CARDIAC PACING WIRES
K011660 · LDF
Weck Closure Systems
Cardiovascular · 84d
Cleared Aug 21, 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · DXT
Medrad, Inc.
Cardiovascular · 56d
Cleared Aug 21, 2001
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
K012020 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 54d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038 · KNK
Jas Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 21, 2001
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
K012104 · KGO
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 47d
Cleared Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
K012422 · GGC
Kamiya Biomedical Co.
Hematology · 22d
Cleared Aug 20, 2001
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · MBF
Biomet, Inc.
Orthopedic · 171d
Cleared Aug 20, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · LGD
Bayer Corp.
Microbiology · 160d
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