FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,820 results
96913–96936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1996
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · DYB
Cordis Corp.
Cardiovascular · 88d
Cleared Oct 11, 1996
REIGEL TUNNELING DEVICE
K962761 · GYK
Cook, Inc.
Neurology · 87d
Cleared Oct 11, 1996
MINIATURE LAPAROSCOPE SET (MINI LAP)
K962799 · GCJ
Richard Wolf GmbH
General & Plastic Surgery · 85d
Cleared Oct 11, 1996
TX BIOPSY NEEDLE
K962905 · FCG
Gallini S.R.L.
Gastroenterology & Urology · 78d
Cleared Oct 11, 1996
SURGICADE GAUZE SPONGE
K962972 · EFQ
Accunex Canada,Inc.
General & Plastic Surgery · 72d
Cleared Oct 11, 1996
FREE CHOICE
K963032 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 67d
Cleared Oct 11, 1996
TRADITION P, PUSH BUTTON HANDPIECE
K963050 · EFB
Midwest Dental Products Corp.
Dental · 66d
Cleared Oct 11, 1996
KUGEL HERNIA PATCH
K963141 · FTL
Douglas Bueschel
General & Plastic Surgery · 59d
Cleared Oct 11, 1996
HEELBO WRAP AROUND VEST
K963294 · FMQ
Heelbo, Inc.
General Hospital · 51d
Cleared Oct 11, 1996
THERMO-PLASTIC SHAVER BLADES
K963332 · HRX
Stryker Endoscopy
Orthopedic · 49d
Cleared Oct 11, 1996
MULTI-PURPOSE MEDICAL TUBE HOLDER
K963365 · KMK
Byrd Medical Devices, Inc.
General Hospital · 45d
Cleared Oct 11, 1996
SAFETY PONCHO/SHOULDER STRAP PONCHO
K963461 · KID
Skil-Care Corp.
Physical Medicine · 38d
Cleared Oct 11, 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538 · JFL
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 11, 1996
PULPDENT DESENSITIZER
K963652 · EBF
Pulpdent Corp.
Dental · 29d
Cleared Oct 11, 1996
EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
K963685 · HHT
North Eos Industries, Inc.
Obstetrics & Gynecology · 38d
Cleared Oct 10, 1996
P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
K954481 · HRY
Johnson & Johnson Professionals, Inc.
Orthopedic · 379d
Cleared Oct 10, 1996
IM C-MENT ACETABULAR CAP
K955137 · JDI
Implant Ideas, LLC
Orthopedic · 332d
Cleared Oct 10, 1996
PARAPAC
K960515 · BTL
Pneupac , Ltd.
Anesthesiology · 248d
Cleared Oct 10, 1996
CONDOM
K960710 · HIS
Polar Latex , Ltd.
Obstetrics & Gynecology · 232d
Cleared Oct 10, 1996
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
K961165 · DSI
Hewlett-Packard Co.
Cardiovascular · 199d
Cleared Oct 10, 1996
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 195d
Cleared Oct 10, 1996
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE...
K961889 · DHB
Diagnostic Products Corp.
Immunology · 147d
Cleared Oct 10, 1996
FACTOR DEFICIENT PLASMA
K961929 · GGP
Universal Reagents, Inc.
Hematology · 146d
Cleared Oct 10, 1996
OHMEDA 3800 PULSE OXIMETER
K962127 · DQA
Ohmeda Medical
Anesthesiology · 129d