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
167881–167904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1979
DEVO OXYGEN CONCENTRATOR, MODEL 955
K792385 · CAW
The Devilbiss Co.
Anesthesiology · 9d
Cleared Dec 05, 1979
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
K792387 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Dec 04, 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · JFH
Clinical Assays, Inc.
Chemistry · 123d
Cleared Dec 04, 1979
P-2 ULTRASONIC ARTERIOGRAPH
K792015 · DPT
D. E. Hokanson, Inc.
Cardiovascular · 60d
Cleared Dec 04, 1979
TEMPTRONIC 100 WATER BATH
K792060 · JTQ
Sybron Corp.
Immunology · 50d
Cleared Dec 04, 1979
DCG DATA TERMINAL
K792071
Del Mar Avionics
General Hospital · 15d
Cleared Dec 04, 1979
MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · DXN
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · DSK
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
MODEL 656 ARRHYTHMIA ANALYZER
K792080 · DXG
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
CONPHAR BLOOD PRESSURE CUFFS
K792108 · DXQ
Conphar, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1979
CONPHAR STETHSCOPE
K792112 · DQD
Conphar, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1979
EMIT-BARBITURATE ASSAY
K792114 · DIS
Syva Co.
Toxicology · 39d
Cleared Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
K792134 · DWP
Shiley, Inc.
Cardiovascular · 43d
Cleared Dec 04, 1979
SANDARE HEMOGLOBIN CONTROLS
K792209 · JPK
Sandare Chemical Co., Inc.
Hematology · 32d
Cleared Dec 04, 1979
TEMPERATURE MONITOR (W/PROBE)
K792257 · FLL
Biotronex Laboratory, Inc.
General Hospital · 25d
Cleared Dec 04, 1979
RH VIEWBOX
K792306 · KSY
Tekpro
Hematology · 18d
Cleared Dec 04, 1979
NORM-TROL
K792310 · JPA
Helena Laboratories
Hematology · 18d
Cleared Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
K792335 · GGP
Helena Laboratories
Hematology · 15d
Cleared Dec 04, 1979
OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR
K792356 · CCL
Oxequip Health Ind.
Anesthesiology · 13d
Cleared Dec 04, 1979
TEE ADAPTER
K792364 · CAF
Airlife, Inc.
Anesthesiology · 11d
Cleared Dec 04, 1979
MOISTURE TRAP
K792390 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 8d
Cleared Nov 30, 1979
LEIF CENTRIFUGAL CYTOLOGY BUCKET
K792032 · IFB
Robert C. Leif, Ph.D.
Pathology · 51d
Cleared Nov 30, 1979
DENTURE BASE RESIN
K792042 · EBI
Dentsply Intl.
Dental · 49d
Cleared Nov 30, 1979
GLYCO-SPIN
K792086 · LCP
Applied Clinical Research Laboratories
Hematology · 44d