Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137617–137640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1988
SWEDE CHAMP (WHEELCHAIR)
K875034 · IOR
Etac Us, Inc.
Physical Medicine · 36d
Cleared Jan 12, 1988
SWEDE PETITE (WHEELCHAIR)
K875035 · IOR
Etac Us, Inc.
Physical Medicine · 36d
Cleared Jan 12, 1988
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · GIO
Sherwood Medical Co.
Hematology · 34d
Cleared Jan 12, 1988
DISPOSABLE STERILE SYRINGE FILTERS
K875122 · KET
Corning Medical & Scientific
Pathology · 28d
Cleared Jan 12, 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 28d
Cleared Jan 12, 1988
ACUSYST-P/3X
K875151 · KJH
Endotronics, Inc.
Pathology · 28d
Cleared Jan 11, 1988
SONOLAYER-V, SAL-38B
K872288 · IYO
Toshiba Medical Systems
Radiology · 209d
Cleared Jan 11, 1988
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
K872895 · CAL
Haemonetics Corp.
Anesthesiology · 172d
Cleared Jan 11, 1988
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
K872942 · LKQ
Clinical Sciences, Inc.
Microbiology · 168d
Cleared Jan 11, 1988
SUPERVISOR SUN GOGGLES(TM)
K873405 · HQY
Eye Communications, Inc.
Ophthalmic · 139d
Cleared Jan 11, 1988
QBC BLOOD BANK SYSTEM
K874147 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Jan 11, 1988
IVT SOUTHEAST ALLERGY SCREEN
K874168 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
IVT NORTHEAST ALLERGY SCREEN
K874169 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.
K874250 · HLP
Richmond Products, Inc.
Ophthalmic · 84d
Cleared Jan 11, 1988
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT
K874251 · HLP
Richmond Products, Inc.
Ophthalmic · 84d
Cleared Jan 11, 1988
SOLOS SINGLE USE TITANIUM TIP
K874334 · HQC
Solos Ophthalmology
Ophthalmic · 81d
Cleared Jan 11, 1988
RAICHEM(TM) ALCOHOL REAGENT
K874382 · DML
Reagents Applications, Inc.
Toxicology · 77d
Cleared Jan 11, 1988
PRESSURE LIMIT CONTROL
K874415 · CBK
Draeger Medical, Inc.
Anesthesiology · 75d
Cleared Jan 11, 1988
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K874621 · CFT
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K874624 · CEP
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
K874626 · LCL
Syva Co.
Toxicology · 62d
Cleared Jan 11, 1988
BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A
K874840 · IZL
Bennett X-Ray Corp.
Radiology · 48d
Cleared Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · JWY
Baxter Healthcare Corp
Microbiology · 42d
Cleared Jan 11, 1988
BILIRUBIN (TOTAL)
K875069 · CIG
Tech-Co, Inc.
Chemistry · 33d