FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136825–136848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1988
LACTATE DEHYDROGENASE (LDH-L)
K880630 · CFH
Tech-Co, Inc.
Chemistry · 29d
Cleared Mar 16, 1988
VISION(R) THYROXINE (T4)
K880662 · KLI
Abbott Laboratories
Chemistry · 28d
Cleared Mar 16, 1988
JMS APHERESIS NEEDLE
K880726 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 22d
Cleared Mar 15, 1988
ADI/B/*/HA-2 STAGE OSSEO. HYDRO. DENTAL IMPLANT
K873939 · DZE
Anchor Implants , Ltd.
Dental · 169d
Cleared Mar 15, 1988
NIDEK UP-2000
K880065 · IYO
Nidek, Inc.
Radiology · 68d
Cleared Mar 15, 1988
VISION CARE/PHAKOSYSTEMS ECHOPACH
K880081 · IYO
Phakosystems, Inc.
Radiology · 64d
Cleared Mar 15, 1988
ION TRAP DETECTOR
K880090 · DOP
Finnigan Corp.
Chemistry · 63d
Cleared Mar 15, 1988
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 15, 1988
GLUCOSE HEXOKINASE
K880236 · CFR
Tech-Neal Scientific, Inc.
Chemistry · 55d
Cleared Mar 15, 1988
TRIGLYCERIDE
K880238 · CDT
Tech-Neal Scientific, Inc.
Chemistry · 55d
Cleared Mar 15, 1988
KONE CALCIUM TEST
K880242 · CJY
The Rupp & Bowman Co.
Chemistry · 55d
Cleared Mar 15, 1988
OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
K880263 · JEB
Orthopedic Systems, Inc.
General & Plastic Surgery · 53d
Cleared Mar 15, 1988
CO2 REAGENT
K880268 · KHS
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 15, 1988
ALKALINE PHOSPHATASE REAGENT SET
K880307 · CJE
Tech-Neal Scientific, Inc.
Chemistry · 50d
Cleared Mar 15, 1988
HCG-NOSTICK
K880328 · JHJ
Organon Teknika Corp.
Chemistry · 49d
Cleared Mar 15, 1988
TELOS DISTAL TARGETING DEVICE
K880381 · HXY
Austin Assoc.
Orthopedic · 48d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
K880395 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880396 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880397 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · JDI
Orthomet, Inc.
Orthopedic · 41d
Cleared Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495 · JJW
Bio-Rad
Chemistry · 40d
Cleared Mar 15, 1988
CONCEP-7-BHCG
K880577 · JHI
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Mar 15, 1988
TRIGLYCERIDES (GPO-TRINDER)
K880628 · CDT
Tech-Co, Inc.
Chemistry · 28d
Cleared Mar 15, 1988
EASY-TEST LACTIC ACID (LA)
K880787 · KHP
Diagnostic Systems
Chemistry · 18d