FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

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175,820 results
134017–134040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
K883539 · JJE
Serono-Baker Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 31, 1988
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
BEHRING TURBITIMER
K883646 · JJQ
Behring Diagnostics, Inc.
Chemistry · 67d
Cleared Oct 31, 1988
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K883699 · LNH
Fonar Corp.
Radiology · 62d
Cleared Oct 31, 1988
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
K883765 · KHQ
Biotecx Laboratories, Inc.
Chemistry · 55d
Cleared Oct 31, 1988
ROCKET INTRAUTERINE SOUND
K883806 · HHM
A & A Medical, Inc.
Obstetrics & Gynecology · 54d
Cleared Oct 31, 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844 · CHH
Hichem Diagnostics
Chemistry · 49d
Cleared Oct 31, 1988
DERATA MEDI-JECTOR V
K883847 · KZE
Derata Corp.
General Hospital · 49d
Cleared Oct 31, 1988
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
K883961 · ESD
Unimax Hearing Instruments
Ear, Nose, Throat · 41d
Cleared Oct 31, 1988
ANALYST THEOPHYLLINE ROTOR
K884002 · KLS
The DU Pont Co.
Toxicology · 40d
Cleared Oct 31, 1988
PRN PLUS + INFUSION SET
K884053 · FPA
Prn Services, Inc.
General Hospital · 35d
Cleared Oct 28, 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · DTB
Oscor Medical Corp.
Cardiovascular · 143d
Cleared Oct 28, 1988
PERMANENT PACING LEAD MODEL RXBJ SERIES
K882462 · DTB
Oscor Medical Corp.
Cardiovascular · 135d
Cleared Oct 28, 1988
COMPAT ENTERAL DELIVERY SYSTEM
K882682 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 122d
Cleared Oct 28, 1988
0.014 PERIPHERAL GUIDE WIRE
K882804 · DQX
Intensive Technology, Inc.
Cardiovascular · 113d
Cleared Oct 28, 1988
SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
K883058 · CAC
Solco Basle, Inc.
Anesthesiology · 101d
Cleared Oct 28, 1988
PMT 3721-1 EPIDURAL KIT
K883314 · CAZ
Progress Mankind Technology
Anesthesiology · 85d
Cleared Oct 28, 1988
PORGES STEPPED NEOPLEX DILATOR
K883526 · KNQ
Porges Corp.
Gastroenterology & Urology · 71d
Cleared Oct 28, 1988
BM-103 BATTERY MODULE
K883877 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 45d
Cleared Oct 28, 1988
3D VASCULAR RECORDER
K883908 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 43d
Cleared Oct 28, 1988
ROTATING HEMOSTATIC VALVE
K883916 · DQY
Devices For Vascular Intervention, Inc.
Cardiovascular · 42d
Cleared Oct 28, 1988
BIO-MEDICUS TUBING CONNECTORS
K883956 · DTL
Bio Medicus, Inc.
Cardiovascular · 39d