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
136849–136872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
K874469 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 87d
Cleared Jan 28, 1988
SUPER FLOSSER
K874471 · JES
U.S. Pacific Corp.
Dental · 87d
Cleared Jan 28, 1988
BISCO PIT AND FISSURE SEALANT
K874556 · EBC
Bisco, Inc.
Dental · 85d
Cleared Jan 28, 1988
BISCO PORCELAIN REPAIR KIT
K874557 · EBC
Bisco, Inc.
Dental · 85d
Cleared Jan 28, 1988
SECURATRODE
K874562 · DRX
Meddev International Corp.
Cardiovascular · 85d
Cleared Jan 28, 1988
MEDTRONIC(R) ORTHOFLEX(TM)
K874884 · BXB
Metronic, Inc.
Physical Medicine · 58d
Cleared Jan 28, 1988
SELF-RETAINING RETRACTOR FOR NEUROSURGERY
K874956 · GZT
Solway, Inc.
Neurology · 57d
Cleared Jan 28, 1988
TRACETS 3000
K875015 · DRX
Lectec Corp.
Cardiovascular · 55d
Cleared Jan 28, 1988
GHAJAR GUIDE TWIST DRILL
K875018 · HBG
Neurodynamics, Inc.
Neurology · 55d
Cleared Jan 28, 1988
FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE
K875041 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 56d
Cleared Jan 28, 1988
ACROMED ADS BONE NAIL DRIVER
K875054 · HWR
Buckman Co., Inc.
Orthopedic · 50d
Cleared Jan 28, 1988
HUDSON CRANINAL BURRS
K875224 · HBE
Tri-Med, Inc.
Neurology · 37d
Cleared Jan 28, 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · GXY
Medtronic Vascular
Neurology · 35d
Cleared Jan 27, 1988
TELEFLEX STEERABLE GUIDEWIRE
K871850 · DQX
Teleflexmedical, Inc.
Cardiovascular · 260d
Cleared Jan 27, 1988
MODIFICATION TO ARKIVE(TM)
K872178 · BSZ
Diatek, Inc.
Anesthesiology · 233d
Cleared Jan 27, 1988
INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM
K873602 · JWH
Intermedics Orthopedics
Orthopedic · 145d
Cleared Jan 27, 1988
MODEL 1859 TUMI/PRESSURE MODULE
K873695 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 135d
Cleared Jan 27, 1988
ACID PHOSPHATASE TEST
K873726 · CKE
King Diagnostics, Inc.
Chemistry · 134d
Cleared Jan 27, 1988
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
K874093 · JDI
Protek, Inc.
Orthopedic · 111d
Cleared Jan 27, 1988
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160 · HJO
Carl Zeiss, Inc.
Ophthalmic · 106d
Cleared Jan 27, 1988
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203 · DBF
Amersham Corp.
Immunology · 104d
Cleared Jan 27, 1988
KREDA DISC
K874252 · HOQ
Richmond Products, Inc.
Ophthalmic · 100d