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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136225–136248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1988
POLYDERM PEC(TM), POROUS ELASTIC COVER
K880964 · KGX
Laivan Corp.
General & Plastic Surgery · 9d
Cleared Mar 17, 1988
WOUND-EVAC RS
K881012 · GCY
Heritage Medical Products
General & Plastic Surgery · 7d
Cleared Mar 16, 1988
REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K871242 · FIP
Medro Systems, Inc.
Gastroenterology & Urology · 355d
Cleared Mar 16, 1988
DRIPRIDE PROVIDE ULTRA
K872059 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 293d
Cleared Mar 16, 1988
BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
K874361 · DSB
Biodynamics Corp.
Cardiovascular · 145d
Cleared Mar 16, 1988
SIXALYZER
K880230 · IKK
Lukens Corp.
Physical Medicine · 56d
Cleared Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · JBQ
Baxter Healthcare Corp
Hematology · 50d
Cleared Mar 16, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496 · JJW
Bio-Rad
Chemistry · 41d
Cleared Mar 16, 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609 · KHS
Technicon Instruments Corp.
Chemistry · 33d
Cleared Mar 16, 1988
ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN
K880617 · JWY
Pasco Laboratories, Inc.
Microbiology · 29d
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