FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136129–136152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1988
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
K880990 · JSY
Alpha-Tec Systems, Inc.
Pathology · 16d
Cleared Mar 24, 1988
EPIPACK
K880999 · KIT
Clonetics Corp.
Pathology · 16d
Cleared Mar 24, 1988
NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
K881067 · BSJ
Medesign, Inc.
Anesthesiology · 10d
Cleared Mar 24, 1988
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Mar 23, 1988
OMNI-VENT, SERIES D
K872113 · CBK
Stein-Gates Medical Equipment, Inc.
Anesthesiology · 296d
Cleared Mar 23, 1988
SDR 3500 (PHILIPS PLATINUM +)
K873937 · IYO
Philips Ultrasound, Inc.
Radiology · 177d
Cleared Mar 23, 1988
LASEGUIDE 600A, 600B, 400A, AND 400B
K874680 · FCS
Laser Peripherals, LLC
Gastroenterology & Urology · 131d
Cleared Mar 23, 1988
IVT WESTERN ALLERGY SCREEN
K875328 · DHB
In Vitro Technologies, Inc.
Immunology · 84d
Cleared Mar 23, 1988
THE DDI SERODOT RUBELLA IGG TEST KIT
K875368 · LFX
Disease Detection International, Inc.
Microbiology · 83d
Cleared Mar 23, 1988
BONE SUTURE FIXATION DEVICE
K880264 · HXY
Orthopedic Systems, Inc.
Orthopedic · 61d
Cleared Mar 23, 1988
FERRIS HYDROPHILIC DRESSING
K880330 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 56d
Cleared Mar 23, 1988
CLP PROTHROMBIN TIME TEST
K880566 · GJS
Creative Laboratory Products, Inc.
Hematology · 42d
Cleared Mar 23, 1988
MODIFICATIONS TO API UNISCEPT (R) KB
K880598 · JWY
Analytical Products, Inc.
Microbiology · 41d
Cleared Mar 23, 1988
CREATININE
K880629 · CGX
Tech-Co, Inc.
Chemistry · 36d
Cleared Mar 23, 1988
CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K881068 · GFO
Creative Laboratory Products, Inc.
Hematology · 9d
Cleared Mar 23, 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125 · LIO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 7d
Cleared Mar 22, 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126 · DTB
Intermedics, Inc.
Cardiovascular · 294d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · DQX
Cordis Corp.
Cardiovascular · 211d
Cleared Mar 22, 1988
VITALOG HMS-3000
K874198 · DQA
Vitalog Corp.
Anesthesiology · 165d
Cleared Mar 22, 1988
BLOOD PRESSURE SLEEVE W/TUBING
K874233 · DXQ
Devcom, Inc.
Cardiovascular · 159d
Cleared Mar 22, 1988
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · LGM
Busse Hospital Disposables, Inc.
General Hospital · 154d
Cleared Mar 22, 1988
LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
K874492 · DQA
Lawrence Medical Systems, Inc.
Anesthesiology · 141d
Cleared Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 104d
Cleared Mar 22, 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · DWF
Dlp, Inc.
Cardiovascular · 82d