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
122833–122856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1991
ITE HEARING AID
K905371 · ESD
Audicare Hearing Center
Ear, Nose, Throat · 106d
Cleared Mar 15, 1991
VIAL ACCESS CANNULA
K905664 · FMI
Baxter Healthcare Corp
General Hospital · 87d
Cleared Mar 15, 1991
KRUPIN EYE VALVE WITH DISK
K905703 · KYF
Hood Laboratories
Ophthalmic · 85d
Cleared Mar 15, 1991
IONOSEAL
K905723 · EJK
Micro-Vac, Inc.
Dental · 85d
Cleared Mar 15, 1991
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · DPT
Hewlett-Packard Co.
Cardiovascular · 81d
Cleared Mar 15, 1991
GDC-3200 DENTAL SOLDER
K910065 · EJT
Deringer-Ney, Inc.
Dental · 65d
Cleared Mar 15, 1991
SPECTRAMAT
K910068 · EBZ
Ivoclar North America, Inc.
Dental · 65d
Cleared Mar 15, 1991
OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)
K910134 · HQZ
Kentucky Optical Co.
Ophthalmic · 65d
Cleared Mar 15, 1991
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K910260 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 52d
Cleared Mar 15, 1991
HELICAL SCAN
K910375 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 15, 1991
7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS
K910529 · ITX
Siemens Ultrasound, Inc.
Radiology · 35d
Cleared Mar 15, 1991
ACCU-MIX AMALGAMATOR
K910632 · EFD
Wykle Research, Inc.
Dental · 30d
Cleared Mar 15, 1991
5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU
K910669 · ITX
Siemens Ultrasound, Inc.
Radiology · 28d
Cleared Mar 15, 1991
ENAMEL ETCHING GEL
K910803 · DYH
Gresco Products, Inc.
Dental · 17d
Cleared Mar 15, 1991
INTEGO
K910904 · HQY
Racal Health & Safety, Inc.
Ophthalmic · 10d
Cleared Mar 14, 1991
TRABECULO-SUPRACHOROIDAL SHUNT
K902296 · KYF
Visionex, Inc.
Ophthalmic · 296d
Cleared Mar 14, 1991
HOWMEDICA HNR SYSTEM
K903563 · LWJ
Howmedica Corp.
Orthopedic · 219d
Cleared Mar 14, 1991
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
K905482 · GAM
Pfizer Hospital Products Group, Inc.
General & Plastic Surgery · 98d
Cleared Mar 14, 1991
ACE RECONSTRUCTIVE PLATE
K905595 · HRS
Ace Medical Co.
Orthopedic · 91d
Cleared Mar 14, 1991
FORCE 10, 20, 30, AND 40
K905605 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Mar 14, 1991
SUTURE APPLIER DEVICE
K905722 · MFJ
Laparomed Corp.
General & Plastic Surgery · 84d
Cleared Mar 14, 1991
LACRIMAL PLUG
K905750 · LZU
Tamcenan Corp.
Ophthalmic · 80d
Cleared Mar 14, 1991
SUNGLASSES (NON-PRESCRIPTION)
K905864 · HQY
The Limited Stores, Inc.
Ophthalmic · 84d
Cleared Mar 14, 1991
SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA)
K910125 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d