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

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176,076 results
79057–79080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 83d
Cleared Aug 09, 2001
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
K011571 · NDC
The RX Files Corp.
General Hospital · 80d
Cleared Aug 09, 2001
BCT SYSTEM
K011665 · JPA
Dade Behring, Inc.
Hematology · 71d
Cleared Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE...
K011730 · LCM
ACON Laboratories, Inc.
Toxicology · 65d
Cleared Aug 09, 2001
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962 · DIO
Advantage Diagnostics Corp.
Toxicology · 48d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Aug 09, 2001
GIBBONS STERILE TROCAR KITS
K012198 · FBQ
Gibbons Surgical Corp.
General & Plastic Surgery · 27d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Aug 09, 2001
IMAGE-X SYSTEM
K012355 · EHD
Tg Group, Inc.
Radiology · 15d
Cleared Aug 09, 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · IXA
Ferrania S.P.A.
Radiology · 14d
Cleared Aug 08, 2001
ANSPACH EMAX DRILL SYSTEM
K011444 · HBC
The Anspach Effort, Inc.
Neurology · 89d
Cleared Aug 08, 2001
REJUVENIQUE MODEL #RJV10
K011935 · NFO
Salton, Inc.
Neurology · 48d
Cleared Aug 08, 2001
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
K012054 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 37d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
LACTOSORB RAPIDFLAP
K003281 · JEY
Biomet, Inc.
Dental · 292d
Cleared Aug 07, 2001
INPULSE DENTAL LASER
K011423 · GEX
Incisive, LLC
General & Plastic Surgery · 90d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
PRAXSYS RELIA TSH TEST
K011527 · JLW
Praxsys Biosystems, Inc.
Chemistry · 82d
Cleared Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
K011695 · NPL
Collagen Matrix, Inc.
Dental · 68d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Ortho Tec, LLC
Orthopedic · 57d
Cleared Aug 07, 2001
PIT AND FISSURE CHEMICAL CURING SEALANT
K011822 · EBC
Rite-Dent Manufacturing Corp.
Dental · 57d
Cleared Aug 07, 2001
GC E-LIGHT
K012134 · EBZ
GC America, Inc.
Dental · 29d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
ACON Laboratories, Inc.
Chemistry · 22d