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
161017–161040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1982
PIONEER II BACK PLATE ELECTRODE
K820122 · DRX
Life Science Instrumentation, Inc.
Cardiovascular · 42d
Cleared Mar 01, 1982
SUNFLOWER
K820123 · FTC
Solana, Inc.
General & Plastic Surgery · 42d
Cleared Mar 01, 1982
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K820135 · DXN
Sybron Corp.
Cardiovascular · 42d
Cleared Mar 01, 1982
BONE BIOPSY SET
K820293 · KNW
The Anspach Effort, Inc.
Gastroenterology & Urology · 26d
Cleared Mar 01, 1982
H-H RICKHAM TYPE RESERVOIR
K820312 · JXG
Holter-Hausner Intl.
Neurology · 24d
Cleared Mar 01, 1982
VPI-FAIR URETHRAL STENT
K820313 · KOD
Vance Products, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 01, 1982
MODEL 3030 ATOMIC ABSORPTION SPECTRO-
K820320 · JXR
The Perkin-Elmer Corp.
Toxicology · 24d
Cleared Mar 01, 1982
RIONET HEARING AID HB-69AS
K820348 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71H
K820349 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71S
K820350 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
ATMOS MIRROR WARMER
K820354 · KAI
Jedmed Instrument Co.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
BECSIC COLLAR
K820366 · IQK
Blackstone & Breglio Industries
Physical Medicine · 20d
Cleared Mar 01, 1982
CURVED FINGER SPLINT
K820380 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
FINGER PROTECTOR
K820381 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
FROG SPLINT
K820382 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
PEEP VALVE
K820404 · BYE
Vital Signs, Inc.
Anesthesiology · 17d
Cleared Feb 24, 1982
AIR ALIVE
K812320 · FRF
Western Systems, Inc.
General Hospital · 191d
Cleared Feb 24, 1982
NLD IMPLANT SET
K813314 · HMX
Design Research Assoc., Inc.
Ophthalmic · 92d
Cleared Feb 24, 1982
MYERSON/KENSON GP POLYMER
K813328 · EBD
Howmedica Corp.
Dental · 92d
Cleared Feb 24, 1982
CAVIDENTIN
K813380 · EMA
Bitan Int'L Marketing Co.
Dental · 85d
Cleared Feb 24, 1982
ADR ULTRASOUND MODELS 4000S & 4000S/L
K813543 · IYO
Adr Ultrasound
Radiology · 65d
Cleared Feb 24, 1982
HYBRID DENTAL PRODUCT
K813550 · EBH
Dentsply Intl.
Dental · 65d
Cleared Feb 24, 1982
EMOTENS
K813569 · GZJ
Electro Medica Office
Neurology · 64d
Cleared Feb 24, 1982
CONPHAR-SCHIOETZ TONOMETER
K813619 · HKY
Conphar, Inc.
Ophthalmic · 57d