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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79225–79248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 24, 2001
VIVA
K011480 · HIS
Richter Rubber Technology Sdn. Bhd.
Obstetrics & Gynecology · 10d
Cleared May 23, 2001
VEGA ULTRASONIC NEBULIZER
K002831 · CAF
Vega Technologies, Inc.
Anesthesiology · 254d
Cleared May 23, 2001
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K003251 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 218d
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL...
K003618 · NDD
Whiteside Biomechanics, Inc.
Orthopedic · 182d
Cleared May 23, 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K004049 · LPL
Optech, Inc.
Ophthalmic · 145d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared May 23, 2001
KM-30 TENS ELECTRODE
K010543 · GXY
Katecho, Inc.
Neurology · 89d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576 · MNI
Depuyacromed
Orthopedic · 85d
Cleared May 23, 2001
CT SPACER
K010680 · CAF
Clinical Technologies, Inc.
Anesthesiology · 77d
Cleared May 23, 2001
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
K010809 · DSA
Rf Industries, Ltd.
Cardiovascular · 68d
Cleared May 23, 2001
CHEMWELL, MODEL 2900
K010877 · CIX
Awareness Technology, Inc.
Chemistry · 61d
Cleared May 23, 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011089 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared May 23, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · DPS
Bci, Inc.
Cardiovascular · 36d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · HRS
Biomet, Inc.
Orthopedic · 30d