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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97873–97896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1996
ORTHOFIX TIBIAL NAILING SYSTEM
K961027 · HSB
Orthofix, Inc.
Orthopedic · 55d
Cleared May 08, 1996
RF IGM ELISA TEST SYSTEM
K961277 · DHR
Zeus Scientific, Inc.
Immunology · 35d
Cleared May 08, 1996
KOLOR +
K961284 · EBF
Sybron Dental Specialties, Inc.
Dental · 65d
Cleared May 08, 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR...
K961471 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared May 07, 1996
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
K944598 · GYB
Chester Labs, Inc.
Neurology · 596d
Cleared May 07, 1996
GRAHAM-FIELD CONDUCTIVE ECG SPRAY
K944599 · GYB
Chester Labs, Inc.
Neurology · 596d
Cleared May 07, 1996
DIGITAL IMAGE ACQUISITION SYSTEM
K950330 · IYO
International Imaging Electronics
Radiology · 466d
Cleared May 07, 1996
ORTHOFAB WHEELCHAIR
K952675 · ITI
Orthofab, Inc.
Physical Medicine · 330d
Cleared May 07, 1996
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K952966 · BZD
Nidek Medical Products, Inc.
Anesthesiology · 315d
Cleared May 07, 1996
ULTRA COMPACT VIDEO IMAGER
K953165 · LMC
International Imaging Electronics
Radiology · 305d
Cleared May 07, 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957 · MKJ
Hewlett-Packard Co.
Cardiovascular · 193d
Cleared May 07, 1996
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · HEX
Welch Allyn, Inc.
Obstetrics & Gynecology · 148d
Cleared May 07, 1996
DSL ACTIVE I-HCG IRMA
K960357 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 103d
Cleared May 07, 1996
ADVANTX LCV+
K960575 · IZI
GE Medical Systems
Radiology · 85d
Cleared May 07, 1996
ECHO-COM FOR MS-WINDOWS VERSION 2.0
K960665 · LLZ
Cone Instruments, Inc.
Radiology · 77d
Cleared May 07, 1996
ACUMED BONE GRAFT SYSTEM
K960711 · KIJ
Acu Med, Inc.
Orthopedic · 76d
Cleared May 07, 1996
COMFORTONE PHS
K960741 · ESD
Comfortone America'S Value Hearing...
Ear, Nose, Throat · 74d
Cleared May 07, 1996
CYSTOSCOPE 0/15/30/70 DEGREES
K960872 · FAJ
Pollux Endoscopy, Inc.
Gastroenterology & Urology · 64d
Cleared May 07, 1996
ECHONET
K960946 · LLZ
Lockheed Martin Communications Systems
Radiology · 60d
Cleared May 07, 1996
DIGIFOCUS COMPACT
K961059 · ESD
Oticon, Inc.
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TECHNA TONE
K961082 · ESD
Techna Tone
Ear, Nose, Throat · 50d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099 · JGS
Johnson & Johnson Clinical...
Chemistry · 49d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
K961115 · CEM
Johnson & Johnson Clinical...
Chemistry · 48d
Cleared May 07, 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 47d