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
153553–153576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1984
DESERET CENTRAL VENOUS CATHETER
K840862 · FOZ
Parke-Davis Co.
General Hospital · 24d
Cleared Mar 19, 1984
PORTASCOOT POWER SEAT
K840866 · INI
E.F. Brewer Co.
Physical Medicine · 21d
Cleared Mar 19, 1984
KEYMED MOBILE ENDOSCOPY PATIENT COUCH
K840920 · FPO
Keymed, Inc.
General Hospital · 18d
Cleared Mar 19, 1984
PLAYTEX SLENDER REGULAR TAMPONS
K841154 · HIL
Playtex, Inc.
Obstetrics & Gynecology
Cleared Mar 19, 1984
DEODORANT SLENDER REG. TAMPONS
K841155 · HIL
Playtex, Inc.
Obstetrics & Gynecology
Cleared Mar 19, 1984
SUCTION TIPS
K841159
Morwel Corp.
General Hospital
Cleared Mar 16, 1984
SATELEC SUPRASSON PIEZOMATIC P2
K832664 · ELC
Spelna, Inc.
Dental · 220d
Cleared Mar 16, 1984
SATELEC PROPHY UNIT PU 2000S
K832674 · ELC
Spelna, Inc.
Dental · 220d
Cleared Mar 16, 1984
ERGO DIAGNOSTIC CARD
K834145 · HOX
American Ergo Systems
Ophthalmic · 106d
Cleared Mar 16, 1984
PLASTIC OPTICAL LENS M-110
K834261 · HQC
U-Molde Systems, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
DENTSPLY G-106 CAVITRON ULTRASONIC
K834283 · ELC
Coopercare, Inc.
Dental · 112d
Cleared Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · HQF
Nidek, Inc.
Ophthalmic · 109d
Cleared Mar 16, 1984
MICRO FORCEPS
K834355 · HNR
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
EYE SPONGE OR SPEAR
K834356 · HOZ
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
K834443 · LIQ
Litton Bionetics
Immunology · 91d
Cleared Mar 16, 1984
PHACO FRAGMENTOR GT-1
K834453 · HQC
Fibra Sonics, Inc.
Ophthalmic · 88d
Cleared Mar 16, 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · JJJ
Corning Medical & Scientific
Toxicology · 86d
Cleared Mar 16, 1984
MICRO VIT FRAGMENTATION SYSTEM
K834537 · HQC
Medical Instrument Development...
Ophthalmic · 98d
Cleared Mar 16, 1984
OCUCARE ULTRASOUND TIP & FREEDOM PACK
K834543 · HQC
Intermedics Intraocular, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
SURGICAL KNIFE
K834546 · HNN
Fine-Cut Diamond Instruments
Ophthalmic · 80d
Cleared Mar 16, 1984
COLTENE BRILLIANT
K840085 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 66d
Cleared Mar 16, 1984
EYE SURGERY INSTRUMENT
K840101 · HOB
Truline Instruments, Inc.
Ophthalmic · 66d
Cleared Mar 16, 1984
CAMTEX 1000
K840134 · JAA
Digital Imaging Co. of America
Radiology · 72d
Cleared Mar 16, 1984
LINEAR ACCELERATOR MULTIPLE EXL 3-4-6
K840136 · IYE
Adac Laboratories
Radiology · 73d