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
133729–133752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1988
INSTAJECT II
K883164 · KZH
Pavel Jordan & Associates, Inc.
General Hospital · 69d
Cleared Oct 04, 1988
PMT VASCULAR CATHETER MODEL NUMBER 3621-1
K883313 · LJS
Pmt Corp.
General Hospital · 60d
Cleared Oct 04, 1988
VASCULON 2 INTRAVENOUS CANNULA
K883415 · FOZ
Ohmeda Medical
General Hospital · 50d
Cleared Oct 04, 1988
MEDALIST EXAMINATION TABLE
K883680 · LGX
Hamilton Industries, Inc.
General Hospital · 36d
Cleared Oct 04, 1988
BERNSCO NEEDLE ADAPTER
K883774 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 28d
Cleared Oct 04, 1988
BERNSCO ELECTROSURGICAL SHIELD
K883823 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 27d
Cleared Oct 04, 1988
MODEL CBX EPILATOR
K884079 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 7d
Cleared Oct 03, 1988
DELFIA(TM) NEONATAL HTSH KIT
K881627 · JLW
Pharmacia, Inc.
Chemistry · 174d
Cleared Oct 03, 1988
A-SORB
K882115 · NAB
Howard Medical Co.
General & Plastic Surgery · 137d
Cleared Oct 03, 1988
VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
K883582 · BTA
Surgidyne, Inc.
General & Plastic Surgery · 42d
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721 · HHW
Cook Ob/Gyn
Obstetrics & Gynecology · 33d
Cleared Oct 03, 1988
QTEST PREGNANCY TEST CONTROL
K883741 · JJX
Quidel Corp.
Chemistry · 32d
Cleared Oct 03, 1988
CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS
K883828 · FXX
Greene International Corp.
General Hospital · 24d
Cleared Oct 03, 1988
TANNING BED
K883929 · FTC
Dallas Tan, Inc.
General & Plastic Surgery · 18d
Cleared Sep 30, 1988
COLORECTAL CANCER RISK DETECTOR (TM)
K874180 · KHE
Pearce Clinical Laboratories, Inc.
Hematology · 352d
Cleared Sep 30, 1988
TOXOPLASMA GONDII IGG ELISA KIT
K875258 · LGD
De Ferris Laboratories, Inc.
Microbiology · 283d
Cleared Sep 30, 1988
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
K880378 · CCL
Lifecare Services, Inc.
Anesthesiology · 247d
Cleared Sep 30, 1988
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · GWL
Nihon Kohden America, Inc.
Neurology · 196d
Cleared Sep 30, 1988
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · CAC
Stryker Corp.
Anesthesiology · 184d
Cleared Sep 30, 1988
REP GLYCO SYSTEM
K881863 · LCP
Helena Laboratories
Hematology · 150d
Cleared Sep 30, 1988
HEPAX (TENS)
K882154 · GZJ
Avl Scientific Corp.
Neurology · 130d
Cleared Sep 30, 1988
URISCREEN
K882211 · JXA
Diatech Diagnostica , Ltd.
Microbiology · 127d
Cleared Sep 30, 1988
STERILE INHALATION WATER TRANSFER SET
K882582 · BTT
Intertech Resources, Inc.
Anesthesiology · 100d
Cleared Sep 30, 1988
BEAR EVC-100 CONTROLLER
K882764 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 86d