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
94681–94704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1997
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · JPA
Sysmex Corp.
Hematology · 98d
Cleared Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · KFF
Organon Teknika Corp.
Hematology · 89d
Cleared Mar 18, 1997
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 89d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4...
K965142 · CEC
Johnson & Johnson Clinical...
Chemistry · 85d
Cleared Mar 18, 1997
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
K965251 · MAJ
Medtronic Vascular
General Hospital · 89d
Cleared Mar 18, 1997
NIDEK CYBERSCAN
K970017 · GEX
Nidek, Inc.
General & Plastic Surgery · 75d
Cleared Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · HET
Smith & Nephew, Inc.
Obstetrics & Gynecology · 62d
Cleared Mar 18, 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK...
K970279 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 54d
Cleared Mar 18, 1997
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · LHI
B.Braun Medical, Inc.
General Hospital · 46d
Cleared Mar 18, 1997
LASER EYE GOGGLES
K970361 · GEX
Stefanovsky & Assoc.
General & Plastic Surgery · 46d
Cleared Mar 18, 1997
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
K970467 · CEP
Excel Scientific, Inc.
Chemistry · 39d
Cleared Mar 18, 1997
PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)
K970613 · LYY
Sti Medical Sdn Bhd
General Hospital · 28d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL...
K970643 · CHP
Johnson & Johnson Clinical...
Chemistry · 26d
Cleared Mar 18, 1997
S.P. 100
K970696 · GZJ
Lsi Intl., Inc.
Neurology · 21d
Cleared Mar 17, 1997
ABC IN-LINE BLOOD SAMPLING KIT
K955663 · CBT
Utah Medical Products, Inc.
Anesthesiology · 460d
Cleared Mar 17, 1997
KIRSCHNER KNEE MODIFIED
K961021 · JWH
Biomet, Inc.
Orthopedic · 368d
Cleared Mar 17, 1997
CPC PROBE
K961380 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 341d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 266d
Cleared Mar 17, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
K963315 · IYO
Vingmed Sound, Inc.
Radiology · 207d
Cleared Mar 17, 1997
EMERGENCY RELIEF KIT SYSTEM
K964029 · LRR
Baxter Healthcare Corp
General & Plastic Surgery · 161d
Cleared Mar 17, 1997
MCL 29 DERMABLATE ERBIUM LASER SYSTEM
K964128 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 153d
Cleared Mar 17, 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD...
K964416 · KWQ
Synthes (Usa)
Orthopedic · 164d
Cleared Mar 17, 1997
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR
K964932 · IOR
L & M Resource Information Service, Inc.
Physical Medicine · 98d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
K964987 · DSP
Datascope Corp.
Cardiovascular · 94d