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
121609–121632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1991
CERAPALL 2
K911668 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
PAGALIN 2
K911675 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
SELECTOR 3
K911677 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Jun 27, 1991
LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC
K912083 · LYY
Sterigard, Inc.
General Hospital · 51d
Cleared Jun 27, 1991
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
K912252 · FST
Fiberoptic Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Jun 26, 1991
MAICO MA800 AUDIOMETER
K911368 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 26, 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · HRY
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
K911810 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
K911811 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
VS1G
K912297 · EJT
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
VS1
K912298 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
VS1B
K912299 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
VS11
K912300 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S1
K912303 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S2
K912304 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S4
K912306 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S33
K912309 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
K912570 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
K912571 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 25, 1991
SLIMCATH (TM)
K903001 · HIT
Gynopharma, Inc.
Ophthalmic · 351d
Cleared Jun 25, 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · BXN
Utah Medical Products, Inc.
Anesthesiology · 223d
Cleared Jun 25, 1991
TURBO SUPPORT CATHETER
K910116 · DQY
Datascope Corp.
Cardiovascular · 166d