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
149737–149760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1985
MEDTRONIC MODEL 6912
K844687 · DTD
Medtronic Vascular
Cardiovascular · 60d
Cleared Feb 01, 1985
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
K844767 · CGI
Biotecx Laboratories, Inc.
Chemistry · 56d
Cleared Feb 01, 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781 · CHL
Shaban Mfg. Co.
Chemistry · 53d
Cleared Feb 01, 1985
DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER
K844783 · LLZ
Adac Laboratories
Radiology · 53d
Cleared Feb 01, 1985
DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER
K844784 · LLZ
Adac Laboratories
Radiology · 53d
Cleared Feb 01, 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · DRT
Spacelabs, Inc.
Cardiovascular · 46d
Cleared Feb 01, 1985
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
K845026 · JLS
Amersham Corp.
Chemistry · 36d
Cleared Feb 01, 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · CGR
Diagnostic Products Corp.
Chemistry · 30d
Cleared Feb 01, 1985
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
K850032 · BSY
Paco Research Corp.
Anesthesiology · 25d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 01, 1985
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
K850136 · DSI
Cardio Data
Cardiovascular · 18d
Cleared Feb 01, 1985
ECONO MATE -OXYGEN CONCENTRATOR
K850253 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 10d
Cleared Jan 31, 1985
COLOR DOPPLER 880
K843643 · DXK
Irex Corp.
Cardiovascular · 136d
Cleared Jan 31, 1985
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K844558 · HIO
Universal Medical Instrument Corp.
Obstetrics & Gynecology · 71d
Cleared Jan 30, 1985
TITANIUM MITTELMEIER TYPE ACETABULAR
K842466 · KWA
American Ortomed Corp.
Orthopedic · 219d
Cleared Jan 30, 1985
UNILOC-CEMENTLESS & SELF TAP ACETABULAR
K842518 · KWA
American Ortomed Corp.
Orthopedic · 204d
Cleared Jan 30, 1985
MEDSENTRY SOFTOUCH SYSTEM
K844499 · FNM
Medsentry Corp.
General Hospital · 71d
Cleared Jan 30, 1985
BIO-STAT III PLATE WASHER
K844552 · JTC
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared Jan 30, 1985
TITERTEK DULUTER/DISPENSER 78-640-00
K844568 · JTC
Flow Laboratories, Inc.
Microbiology · 68d
Cleared Jan 30, 1985
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
K844571 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 68d
Cleared Jan 30, 1985
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
K844634 · JSM
Precision Dynamics Corp.
Microbiology · 64d
Cleared Jan 30, 1985
POLYSTAT, BIOLOGICAL STAIN
K844640 · IAB
Surgipath Medical Industries, Inc.
Pathology · 63d
Cleared Jan 29, 1985
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
K842039 · KNZ
Argon Medical Corp.
Gastroenterology & Urology · 253d
Cleared Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
K842216 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 239d