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
149785–149808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1985
CARDIOVIT CV-3
K841254 · DPS
Schiller AG
Cardiovascular · 304d
Cleared Jan 24, 1985
PDS POLYDIOXANONE MESH
K844228 · FTM
Ethicon, Inc.
General & Plastic Surgery · 84d
Cleared Jan 24, 1985
INTERCEPTOR, 662-01
K844279 · GZJ
Intermedics, Inc.
Neurology · 80d
Cleared Jan 24, 1985
SUNDT-KEES REINFORCING ANEURYSM CLIP
K844352 · HCH
Kees Surgical Specialty Co., Inc.
Neurology · 76d
Cleared Jan 24, 1985
GORE-TEX TUNNELER
K844584 · DWS
W.L. Gore & Associates, Inc.
Cardiovascular · 62d
Cleared Jan 24, 1985
PACE AID MODEL 53
K844811 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 44d
Cleared Jan 24, 1985
OMNIMED NASAL OXYGEN CANNULA
K850066 · CAT
Omni Intl., Inc.
Anesthesiology · 16d
Cleared Jan 24, 1985
AIRCO NITROUS OXIDE REGULATOR
K850106 · CAN
Airco, Inc.
Anesthesiology · 13d
Cleared Jan 24, 1985
AIRES TUOHY NEEDLES 17GA. X 4 1/2
K850111 · BSP
Aries Medical, Inc.
Anesthesiology · 10d
Cleared Jan 23, 1985
MX2 ELECTRONIC STETHOSCOPE
K842705 · DQD
Medmax, Inc.
Cardiovascular · 196d
Cleared Jan 23, 1985
HEARING AID, UNITRON UE12-PPL
K843246 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 156d
Cleared Jan 23, 1985
IMSI/METRIPOND GRIPPER PLATE
K843370 · HRS
Intl. Management Services, Inc.
Orthopedic · 148d
Cleared Jan 23, 1985
MECON X (TEN)
K843484 · ESD
Mecon Labs
Ear, Nose, Throat · 139d
Cleared Jan 23, 1985
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · DXO
Gould, Inc.
Cardiovascular · 104d
Cleared Jan 23, 1985
SONOCARE
K844034 · DYO
Echo Ultrasound
Dental · 99d
Cleared Jan 23, 1985
DR. HESSEL'S INSECT POISON REMOVER
K844048 · KYP
Medie Group
General Hospital · 98d
Cleared Jan 23, 1985
BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
K844052
Woodroof Laboratories, Inc.
General & Plastic Surgery · 97d
Cleared Jan 23, 1985
MEDO BUBBLE BATH MA-80, 400, 600 & 700
K844064 · ILJ
Medo U.S.A., Inc.
Physical Medicine · 97d
Cleared Jan 23, 1985
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · GZJ
Biomedical Life Systems, Inc.
Neurology · 96d
Cleared Jan 23, 1985
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
K844120 · GXX
Echo Ultrasound
Neurology · 92d
Cleared Jan 23, 1985
HOLDSTER ARM RETENTION SYSTEM
K844157
P.G.L. Medical
Physical Medicine · 91d
Cleared Jan 23, 1985
PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
K844176 · FRP
Premie Comfort Products
General Hospital · 90d
Cleared Jan 23, 1985
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
K844247 · GXX
Technicare Corp.
Neurology · 83d
Cleared Jan 23, 1985
OSADA ENAC
K844250 · ELC
Osada Electric Co., Ltd.
Dental · 82d