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
118105–118128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1992
CHIN WAFER
K921581 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared May 06, 1992
FLOWERS MEDIAL MALAR IMPLANT
K921582 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared May 05, 1992
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
K912145 · CCE
S & W Medico Teknik
Anesthesiology · 392d
Cleared May 05, 1992
BUD MAXILLOFACIAL IMPLANT SYSTEM
K913688 · JEY
Bud Industries, Inc.
Dental · 260d
Cleared May 05, 1992
SIDESTREAM DRUG NEBULIZER
K914152 · CAF
Medic-Aid , Ltd.
Anesthesiology · 232d
Cleared May 05, 1992
BTP(TM) CENTRALINE(TM) SUIT
K914615 · FXO
Btp Industries, Inc.
General Hospital · 201d
Cleared May 05, 1992
SCALPEL BLADE REMOVER (BLADEGARD)
K915119 · GES
Intergrated Visual, Inc.
General & Plastic Surgery · 174d
Cleared May 05, 1992
E-Z GOLD TOOTH FILLING MATERIAL
K915507 · EJT
Lloyd Baum Center, Inc.
Dental · 148d
Cleared May 05, 1992
THE SELBY SYSTEM
K920102 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 117d
Cleared May 05, 1992
GDC 3367
K920922 · EJS
Deringer-Ney, Inc.
Dental · 67d
Cleared May 05, 1992
MINIDAM
K921117 · DYN
Delsan Dental Systems
Dental · 57d
Cleared May 05, 1992
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
K921245 · DYH
Ormco Corp.
Dental · 50d
Cleared May 05, 1992
CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
K921464 · GBQ
Trinity Laboratories, Inc.
General & Plastic Surgery · 39d
Cleared May 05, 1992
TELETOM(R)
K921626 · FQO
Berchtold Holding GmbH
General & Plastic Surgery · 29d
Cleared May 04, 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911202 · BSP
Pajunk GmbH
Anesthesiology · 412d
Cleared May 04, 1992
CHAGAS' IGG ELISA TEST
K911233 · MIU
Gull Laboratories, Inc.
Microbiology · 411d
Cleared May 04, 1992
RUBALEX, MODIFICATION
K912391 · LQN
Orion Corp.
Microbiology · 346d
Cleared May 04, 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · GZJ
Biomedical Life Systems, Inc.
Neurology · 168d
Cleared May 04, 1992
CAPTIA CMV-TA
K915479 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared May 04, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI
K915896 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 137d
Cleared May 04, 1992
INSERTION
K920515 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 90d
Cleared May 04, 1992
AIR MEDICA III
K920710 · EIA
Hinatawada Seimitsu Mfg. Co., Ltd.
Dental · 76d
Cleared May 04, 1992
JACE MODEL PM-410 HAND CPM DEVICE
K921351 · JFA
Jace Systems, Inc.
Physical Medicine · 46d
Cleared May 04, 1992
AMPHETAMINES EIA TEST
K921554 · DKZ
Diagnostic Reagents, Inc.
Toxicology · 33d