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
164569–164592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1981
DIASONICS SMALL PARTS SCANNER
K802979 · IYN
Diasonics, Inc.
Radiology · 62d
Cleared Jan 22, 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 57d
Cleared Jan 22, 1981
PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
K803032 · KPQ
Pfizer Medical Systems, Inc.
Radiology · 52d
Cleared Jan 22, 1981
SUNMAKER (SUN TANNING BED)
K803090 · LEJ
Sunmaker, Inc.
Radiology · 45d
Cleared Jan 22, 1981
TECHNY REX 3000 MOBILE X-RAY UNIT
K803103 · IZL
Tecnomed, Inc.
Radiology · 44d
Cleared Jan 22, 1981
TILTING IMAGING TABLE #846T
K803120 · KXJ
Quinton, Inc.
Radiology · 42d
Cleared Jan 22, 1981
SIDOS U.
K803124 · KPQ
Siemens Corp.
Radiology · 42d
Cleared Jan 22, 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · DXY
Telectronics, Inc.
Cardiovascular · 37d
Cleared Jan 22, 1981
CSG-FLOW CONTROL VALVE
K803257 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 30d
Cleared Jan 22, 1981
CRITERION II RHYTHM PROFILE MONITOR
K803315 · DXH
Dart Medical Equipment
Cardiovascular · 23d
Cleared Jan 22, 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · DTM
Delta Medical Industries
Cardiovascular · 9d
Cleared Jan 21, 1981
MARK V DUPLEX ULTRASONIC SCAN SYS.
K802438 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 107d
Cleared Jan 21, 1981
IMMUNOREACTIVE ESTRIOL RIA KIT
K802754 · CGI
Microanalytic Research, Inc.
Chemistry · 79d
Cleared Jan 21, 1981
ACRODISC FILTER ASSEMBLY
K802765 · FPB
Gelman Sciences, Inc.
Chemistry · 78d
Cleared Jan 21, 1981
NORMAL AND ELEVATED CONTROL FOR GLYCO.
K803186 · LCP
Applied Clinical Research Laboratories
Chemistry · 36d
Cleared Jan 21, 1981
IRRIGATION SET W/BULB SYRINGE
K803200 · KYZ
Walpak Co.
General Hospital · 35d
Cleared Jan 21, 1981
IRRIGATION PISTON
K803204 · FMF
Walpak Co.
General Hospital · 35d
Cleared Jan 21, 1981
SUCTION PROBE
K803206 · JOL
Bemis Health Care
General Hospital · 35d
Cleared Jan 21, 1981
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · GKZ
Abbott Laboratories
Microbiology · 33d
Cleared Jan 21, 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278 · CEP
Immuno Nuclear Corp.
Chemistry · 23d
Cleared Jan 21, 1981
'NO-BOIL' FOLIC ACID KIT
K810003
Diagnostic Products Corp.
Chemistry · 15d
Cleared Jan 21, 1981
CORTI-SHURE
K810033 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 15d
Cleared Jan 16, 1981
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
K801771 · LGL
Isolab, Inc.
Hematology · 172d
Cleared Jan 16, 1981
DIALYIS START CARE KIT
K802361 · FKG
Med-Pak Corp.
Gastroenterology & Urology · 112d