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
78697–78720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2001
GOLD CORE 73 LS
K011362 · EJT
Jeneric/Pentron, Inc.
Dental · 26d
Cleared May 29, 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · MEG
Safety Syringes, Inc.
General Hospital · 25d
Cleared May 29, 2001
JEWEL MPS
K011374 · IOR
Vestil Manufacturing Corp.
Physical Medicine · 25d
Cleared May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · MOS
Mri Devices Corp.
Radiology · 193d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · HWC
Bionx Implants, Inc.
Orthopedic · 88d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · MNI
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · MGQ
Ambu, Inc.
General & Plastic Surgery · 87d
Cleared May 25, 2001
GOODNET
K010763 · LLZ
Goodman Co., Ltd.
Radiology · 72d
Cleared May 25, 2001
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT...
K010947 · LYY
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 57d
Cleared May 25, 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · LYZ
Allegiance Healthcare Corp.
General Hospital · 37d
Cleared May 25, 2001
RADIUS COUGAR WIRE
K011287 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 28d
Cleared May 25, 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT...
K011376 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 21d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · ERL
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared May 24, 2001
HEMODIALYSIS TUBING SETS
K001971 · FIB
Ofi Biomedica S.P.A.
Gastroenterology & Urology · 330d
Cleared May 24, 2001
SPO2 WRAP SENSOR
K002848 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 253d
Cleared May 24, 2001
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
K010533 · FTL
Injectx, Inc.
General & Plastic Surgery · 90d
Cleared May 24, 2001
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · FMQ
Skil-Care Corp.
General Hospital · 66d
Cleared May 24, 2001
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K010858 · MYI
Id Biomedical Corp.
Microbiology · 63d
Cleared May 24, 2001
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
K011004 · FMI
Diasol, Inc.
General Hospital · 50d
Cleared May 24, 2001
ALPCO MILENIA ANTI-TPO ELISA
K011201 · JZO
American Laboratory Products Co., Ltd.
Immunology · 35d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · JWH
Plus Orthopedics
Orthopedic · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · JWH
Plus Orthopedics
Orthopedic · 27d
Cleared May 24, 2001
ULTRAGUIDE MR-GUIDE 3000
K011418 · LNH
Ultraguide , Ltd.
Radiology · 15d