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
117913–117936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1992
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · NAB
Trinity Laboratories, Inc.
General & Plastic Surgery · 128d
Cleared May 29, 1992
OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE
K920431 · JAQ
Omnitron Intl., Inc.
Radiology · 116d
Cleared May 29, 1992
PROTECTIVE RADIOGRAFIC GLOVE
K920538 · IWP
Burkhart Roentgen Intl., Inc.
Radiology · 114d
Cleared May 29, 1992
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND
K920644 · JEQ
Fairform Mfg., Co., Ltd.
Dental · 107d
Cleared May 29, 1992
UROLOGICAL X-RAY TABLE HS-10A
K920726 · IXR
Shimadzu Medical Systems
Radiology · 101d
Cleared May 29, 1992
X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
K920731 · ITY
Shimadzu Medical Systems
Radiology · 101d
Cleared May 29, 1992
ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER
K920847 · FZP
Ethicon, Inc.
General & Plastic Surgery · 94d
Cleared May 29, 1992
FTS-200 GAS SYSTEM
K920944 · BSZ
Trek Medical Products, Inc.
Anesthesiology · 88d
Cleared May 29, 1992
KALTOSTAT FORTEX WOUND DRESSING
K921009 · KMF
Calgon Vestal Div.
General & Plastic Surgery · 87d
Cleared May 29, 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · ITX
Hewlett-Packard Co.
Radiology · 86d
Cleared May 29, 1992
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
K921099 · LCX
Syntron Bioresearch, Inc.
Chemistry · 81d
Cleared May 29, 1992
TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
K921227 · NAB
Courtaulds Fibers, Inc.
General & Plastic Surgery · 77d
Cleared May 29, 1992
STERILE,DISPOSABLE EYE DRESSING
K921349 · HMP
Deroyal Industries, Inc.
General & Plastic Surgery · 71d
Cleared May 29, 1992
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178 · BYE
Puritan Bennett Corp.
Anesthesiology · 21d
Cleared May 28, 1992
BSM-2100A CONFIGURED PATIENT MONITOR
K914092 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 259d
Cleared May 28, 1992
ELPHA 2000
K914231 · IPF
Biometer Intl. A/S
Physical Medicine · 251d
Cleared May 28, 1992
SCANDIPLAN - VERSION 338
K914926 · KPQ
Scanditronix, Inc.
Radiology · 206d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357 · NAE
Medtronic Vascular
General & Plastic Surgery · 183d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359 · NAE
Medtronic Vascular
General & Plastic Surgery · 183d
Cleared May 28, 1992
LSF HA COATED FEMORAL HIP
K915617 · MEH
Implant Technology, Inc.
Orthopedic · 164d
Cleared May 28, 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · JZG
Elias U.S.A., Inc.
Immunology · 136d
Cleared May 28, 1992
ULTRA-VISION RAPID INTENSIFYING SCREEN
K920190 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 134d
Cleared May 28, 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
K920200 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 134d
Cleared May 28, 1992
RADIOLOGICAL PROTECTIVE EYE SHIELD
K920540 · IWS
Burkhart Roentgen Intl., Inc.
Radiology · 113d