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
131281–131304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1989
CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR.
K892907 · EJT
Deringer-Ney, Inc.
Dental · 47d
Cleared Jun 06, 1989
PATIENT EXAMINATION GLOVES
K892985 · LYY
Eac Rubber Industries (M) Sdn. Bhd.
General Hospital · 55d
Cleared Jun 06, 1989
ARGELITE 54+
K893010 · EJT
Argen Precious Metals, Inc.
Dental · 43d
Cleared Jun 06, 1989
DIGITAL SPOT IMAGING (DSI)
K893131 · JAA
Philips Medical Systems, Inc.
Radiology · 42d
Cleared Jun 06, 1989
ALMATEX EXAM GLOVES (MFG. CONCEPT RUBBER)
K893148 · LYY
Healthgard Medical Products Ltd....
General Hospital · 53d
Cleared Jun 06, 1989
ARGENCO W-LITE
K893228 · EJT
Argen Precious Metals, Inc.
Dental · 40d
Cleared Jun 06, 1989
ARGENCO WLF
K893238 · EJT
Argen Precious Metals, Inc.
Dental · 39d
Cleared Jun 06, 1989
ARGENCO WR+
K893244 · EJT
Argen Precious Metals, Inc.
Dental · 39d
Cleared Jun 05, 1989
NICOLET NEUROPORT/ACE SYSTEM
K883781 · IKN
Nicolet Instrument Corp.
Neurology · 272d
Cleared Jun 05, 1989
MEDIZIV CENTRAL VEIN CATHETER
K884491 · DQY
Mediziv Medical Devices, Ltd.
Cardiovascular · 222d
Cleared Jun 05, 1989
LASERCOMP MODEL: 10 STAR 10
K885170 · GEX
Laser-West
General & Plastic Surgery · 174d
Cleared Jun 05, 1989
EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET
K885257 · GEX
Living Technology, Inc.
General & Plastic Surgery · 164d
Cleared Jun 05, 1989
ALTA HOLLOW TIBIAL RODS
K890936 · HSB
Howmedica Corp.
Orthopedic · 101d
Cleared Jun 05, 1989
SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER
K891238 · IYN
Siemens Ultrasound, Inc.
Radiology · 90d
Cleared Jun 05, 1989
HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
K891610 · HOD
Keeler Instruments, Inc.
Ophthalmic · 77d
Cleared Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905 · DTB
Pacesetter Systems
Cardiovascular · 70d
Cleared Jun 05, 1989
BARD(R) TIP DEFLECTING ELECTRODE CATHETER
K891908 · DRF
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Jun 05, 1989
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52
K891998 · NAD
Elwyn Industries
General & Plastic Surgery · 69d
Cleared Jun 05, 1989
LIFEPAK 250 DEFIBRILLATOR/MONITOR
K892065 · MKJ
Physio-Control Corp.
Cardiovascular · 67d
Cleared Jun 05, 1989
MT9000 CHART RECORDER
K892067 · DSH
Astro-Med, Inc.
Cardiovascular · 67d
Cleared Jun 05, 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360 · FRO
Pfizer, Inc.
General & Plastic Surgery · 60d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · HJM
Keeler Instruments, Inc.
Ophthalmic · 41d