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
146881–146904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1985
DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
K853558
American White Cross, Inc.
General & Plastic Surgery · 10d
Cleared Sep 04, 1985
ASCON OPHTHALMIC SPONGE
K852055 · HOZ
Ascon Medical Instruments, Ltd.
Ophthalmic · 118d
Cleared Sep 04, 1985
SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
K852386 · LPN
Barnes-Hind, Inc.
Ophthalmic · 91d
Cleared Sep 04, 1985
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · JFH
Diagnostic Products Corp.
Chemistry · 61d
Cleared Sep 04, 1985
WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST
K852949 · KZF
Welch Allyn, Inc.
General Hospital · 55d
Cleared Sep 04, 1985
HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
K853006 · JHI
Modern Diagnostics, Inc.
Chemistry · 50d
Cleared Sep 04, 1985
MST MODEL #ARLG-5
K853061
Marlo Surgical Technology
Ophthalmic · 47d
Cleared Sep 04, 1985
ACU-SLIDE-TEST
K853247 · JHJ
Cal-Tech Diagnostics, Inc.
Toxicology · 34d
Cleared Sep 04, 1985
FREEMAN UNI-COMPARTMENTAL KNEE
K853268 · HSX
Protek, Inc.
Orthopedic · 30d
Cleared Sep 04, 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372 · KLS
Electro-Nucleonics Laboratories, Inc.
Toxicology · 23d
Cleared Sep 04, 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · CFR
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Sep 04, 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · CEM
American Dade
Chemistry · 12d
Cleared Sep 03, 1985
ECLIPSE SELF ADHERING ELECTRODE
K850646 · GXY
Todd Medical, Inc.
Neurology · 196d
Cleared Sep 03, 1985
INTRAORAL DENTAL X-RAY SYSTEM 70-X
K851095 · EHD
Trophy Radiologie
Radiology · 168d
Cleared Sep 03, 1985
OXYGEN DELIVERY MEASURING DEVICE
K851288 · CAX
Bar-Dix, Inc.
Anesthesiology · 155d
Cleared Sep 03, 1985
HEATED RESPIRATORY HUMIDIFIER
K851879 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 127d
Cleared Sep 03, 1985
ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
K852228 · BZT
Sensortek, Inc.
Anesthesiology · 104d
Cleared Sep 03, 1985
POSICAM TM(MODEL 3.2,4.3,6.5)
K852239 · KPS
Position Corp.
Radiology · 103d
Cleared Sep 03, 1985
RHYNOSTAT H-12 & V-22
K852349 · KPR
Remesta Medical Corp.
Radiology · 95d
Cleared Sep 03, 1985
SINGLE USE ARTHROSCOPY ELECTRODE
K852355 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 92d
Cleared Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · JPK
Abbott Diagnostics
Hematology · 91d
Cleared Sep 03, 1985
CELL SAVER SUCTION SYSTEM
K852425 · CAC
Haemonetics Corp.
Anesthesiology · 88d
Cleared Sep 03, 1985
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · CDM
Miles Laboratories, Inc.
Chemistry · 76d
Cleared Sep 03, 1985
#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG
K853065 · CAI
Sigma Medical, Inc.
Anesthesiology · 46d