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
135361–135384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1988
COOL EYE(TM) EYE PROTECTOR
K881135 · HOY
Cool Eyes, Inc.
Ophthalmic · 114d
Cleared Jul 08, 1988
BLOOD PH CAPILLARY TUBES, HEPARIN
K881188 · CHL
Helps Products, Inc.
Chemistry · 109d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM TF 1000
K881386 · IZO
General Medical Merate S.P.A
Radiology · 98d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM, TF 800
K881387 · IZO
Absolute X-Ray Corp.
Radiology · 98d
Cleared Jul 08, 1988
LIQUI-SERA SERUM ALCOHOL CONTROLS
K881430 · JJX
Biodiagnostic Intl
Toxicology · 94d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · JJY
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 08, 1988
SITZMARKS
K881609 · FFX
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 08, 1988
4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
K881619 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Jul 08, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639 · CEK
Eastman Kodak Company
Chemistry · 85d
Cleared Jul 08, 1988
ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE
K881654 · FMI
Medical Safety Products, Inc.
General Hospital · 84d
Cleared Jul 08, 1988
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Jul 08, 1988
LINDLEY II RESUSCITATOR
K881689 · BYT
Lindley Resuscitator, Inc.
Anesthesiology · 80d
Cleared Jul 08, 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · CAC
Shiley, Inc.
Anesthesiology · 80d
Cleared Jul 08, 1988
IMMUNOCARD(TM) HCG II TEST KIT
K881709 · JHI
Disease Detection International, Inc.
Chemistry · 79d
Cleared Jul 08, 1988
BIOTROL ALKALINE PHOSPHATASE
K881742 · CJE
Biotrol, USA, Inc.
Chemistry · 77d
Cleared Jul 08, 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · JMO
Data Medical Associates, Inc.
Chemistry · 74d
Cleared Jul 08, 1988
IVORY FINDER SET
K881794 · HCY
Ivory Instruments Co.
Obstetrics & Gynecology · 73d
Cleared Jul 08, 1988
ALPINE PORTABLE OXYGEN GENERATOR
K881802 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 71d
Cleared Jul 08, 1988
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
K881846 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 67d
Cleared Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · JJN
Helena Laboratories
Chemistry · 67d
Cleared Jul 08, 1988
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
K881894 · GOD
Cambridge Bioscience Corp.
Microbiology · 64d
Cleared Jul 08, 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
K881907 · KHE
Enzo Biochem, Inc.
Hematology · 63d
Cleared Jul 08, 1988
PROTECTO-SHIELD
K881913 · FXX
Syntech Mfg. Services
General Hospital · 60d
Cleared Jul 08, 1988
MONOCLONAL RADIAL IMMUNODIFFUSION KIT
K881928 · CFQ
The Binding Site, Ltd.
Immunology · 60d