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
143665–143688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1986
APLICARE SKIN PROTECTANT SWABSTICK
K861558 · NEC
Aplicare, Inc.
General & Plastic Surgery · 40d
Cleared Jun 04, 1986
RUBALEX (REVISED VERSION)
K861881 · LQN
Orion Corp.
Microbiology · 27d
Cleared Jun 04, 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · KKX
Deroyal Industries, Inc.
General Hospital · 15d
Cleared Jun 04, 1986
PACH-PEN SURGICAL DRAPE
K862016 · KKX
Oculab, Inc.
General Hospital · 7d
Cleared Jun 03, 1986
DIRECTATEX STREP A
K861575 · GTY
Pacific Biotech, Inc.
Microbiology · 36d
Cleared Jun 03, 1986
HIPPURATE HYDROLYSIS TEST
K861888 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared Jun 03, 1986
D'ALA RAPID TEST
K861889 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared Jun 03, 1986
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
K861890 · PPM
Richard-Allan Medical Ind., Inc.
Pathology · 18d
Cleared Jun 02, 1986
CARDIOCAP MONITOR
K853953 · DRT
Instrumentarium Corp.
Cardiovascular · 250d
Cleared Jun 02, 1986
THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
K854856 · DWJ
Thermorite, Inc.
Cardiovascular · 179d
Cleared Jun 02, 1986
GORDON DIAGNOSTIC SYSTEM MODEL I
K854903 · LQD
Clinical Diagnostics, Inc.
Neurology · 175d
Cleared Jun 02, 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · DXN
Mennen Medical, Inc.
Cardiovascular · 174d
Cleared Jun 02, 1986
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
K860121 · DPT
NuMED, Inc.
Cardiovascular · 140d
Cleared Jun 02, 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233 · HEM
General Electric Co.
Obstetrics & Gynecology · 131d
Cleared Jun 02, 1986
VOLUME CONTROL SET WITH EXTENSION
K860616 · FPA
Med Fusion Systems, Inc.
General Hospital · 103d
Cleared Jun 02, 1986
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
K860956 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
K860957 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
EASISTIM
K861091 · KOI
Promed Corp.
Anesthesiology · 70d
Cleared Jun 02, 1986
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
K861226 · KRJ
Medical, Inc.
Cardiovascular · 62d
Cleared Jun 02, 1986
HIGH FLOW I.V. SET
K861275 · FPA
Migada, Ltd.
General Hospital · 56d
Cleared Jun 02, 1986
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
K861277 · DRY
Critichem, Inc.
Cardiovascular · 56d
Cleared Jun 02, 1986
ROHO HEEL PAD
K861327 · KIC
Roho, Inc.
Physical Medicine · 54d
Cleared Jun 02, 1986
BEHING-THE-EAR HEARING AID SERIES SP
K861597 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 02, 1986
CHURCHILL EXTENSION TUBE
K861626 · FPK
Churchill Corp.
General Hospital · 41d