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
150337–150360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1984
CREDENT RADIOPAQUE CROWN & BRIDE
K842476 · EBI
Credent Co.
Dental · 161d
Cleared Dec 03, 1984
CREDENT RADIOPAQUE DENTURE RESIN
K842477 · EBI
Credent Co.
Dental · 161d
Cleared Dec 03, 1984
DESERET INTRAVASCULAR CATHETER
K843033 · FOZ
Parke-Davis Co.
General Hospital · 124d
Cleared Dec 03, 1984
HEARING AIDS 372 & 372 AI
K843068 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 119d
Cleared Dec 03, 1984
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE
K843171 · DZC
Berkley and Co.
Dental · 112d
Cleared Dec 03, 1984
ACTIVE VERTICAL CORRECTOR ACTIVE BITE
K843344 · ECO
Active Vertical Correctors, Inc.
Dental · 98d
Cleared Dec 03, 1984
TRANSDUCER FOR KONTROL 5MHZ SIGMA 20
K843355 · MHZ
Kontron Instruments, Inc.
Neurology · 98d
Cleared Dec 03, 1984
PLAYTEX BABY POWDER DEODORANT TAMPONS
K843551 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 03, 1984
AUDIOMETER
K843618 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared Dec 03, 1984
ISOSTATIC CONDENSER
K843901 · EKG
Shofu Dental Corp.
Dental · 61d
Cleared Dec 03, 1984
THYMATRON
K843923 · QGH
Somatics, Inc.
Neurology · 59d
Cleared Dec 03, 1984
ENZYGNOST BETA-2 MICROGLOBULIN TEST
K843967 · JZG
Behring Diagnostics, Inc.
Microbiology · 53d
Cleared Dec 03, 1984
C-22 PIT & FISSURE SEALANT
K844057 · EBC
Pentron Corp.
Dental · 46d
Cleared Dec 03, 1984
RIONET HEARING AID HB-34AS
K844059 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Dec 03, 1984
TA-201 CLINICAL AUDIOMETER
K844069 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 46d
Cleared Dec 03, 1984
ORAPIK PERIODONTAL SCALER
K844238 · JET
Dental Concepts, LLC
Dental · 32d
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 03, 1984
TIGER BAND
K844324 · DZN
World Wide Outdoor Marketing
Dental · 26d
Cleared Dec 03, 1984
OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE
K844326 · EBF
Coe Laboratories, Inc.
Dental · 26d
Cleared Dec 03, 1984
SURFLEX F
K844329 · ELW
G-C Intl. Corp.
Dental · 26d
Cleared Dec 03, 1984
SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS
K844349 · ELM
Ivoclar USA, Inc.
Dental · 24d
Cleared Nov 30, 1984
COUNT-A-PART PLUS
K841809 · JPK
Diagnostic Technology, Inc.
Hematology · 213d
Cleared Nov 30, 1984
TONGUE DEPRESSOR
K842461 · FMA
The Torrent Corp.
General Hospital · 161d
Cleared Nov 30, 1984
RESOLVE-CSF
K843122 · DFI
Isolab, Inc.
Chemistry · 114d