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
77809–77832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 67d
Cleared Aug 22, 2001
JEL-20
K012303 · EJS
J.F. Jelenko & Co., Inc.
Dental · 33d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Sulzer Spine-Tech
Orthopedic · 30d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Aug 22, 2001
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
K012533 · DQA
Osi Medical, Inc.
Anesthesiology · 16d
Cleared Aug 22, 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · DZE
Straumann USA
Dental · 5d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 159d
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