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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112129–112152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1993
SIGMA 7000 AND SIGMA70002
K926191 · FRN
Sigma
General Hospital · 265d
Cleared Aug 31, 1993
MOBILAIRE LIQUID OXYGEN SYSTEMS
K926267 · BYJ
Invacare Corp.
Anesthesiology · 256d
Cleared Aug 31, 1993
DANTEC MAGNETIC STIMULATOR MAGPRO
K926516 · GWF
Dantec Medical, Inc.
Neurology · 244d
Cleared Aug 31, 1993
MSP OPHTHALMIC (EYE SPUD)
K931449 · HNA
Medical Sterile Products, Inc.
Ophthalmic · 161d
Cleared Aug 31, 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
K931662 · DYB
Pace Medical
Cardiovascular · 148d
Cleared Aug 31, 1993
OLYMPUS REPLY GLUCOSE REAGENT
K931744 · JJE
Olympus Corp.
Chemistry · 147d
Cleared Aug 31, 1993
10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
K932762 · GCS
Inman Medical Corp.
Gastroenterology & Urology · 84d
Cleared Aug 31, 1993
FRAMES, SPECTACLE
K932813 · HQZ
Rainbow Optics, Inc.
Ophthalmic · 83d
Cleared Aug 31, 1993
SPECTACLE FRAMES
K932906 · HQZ
U.S. Optics, Inc.
Ophthalmic · 76d
Cleared Aug 31, 1993
SPECTACLE FRAMES
K933280 · HQZ
U.S. Optical
Ophthalmic · 56d
Cleared Aug 30, 1993
FUKUDA DENSHI MODEL UF-4500
K922208 · IYO
Fukuda Denshi USA, Inc.
Radiology · 475d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · DSP
Boston Scientific Corp
Cardiovascular · 276d
Cleared Aug 30, 1993
GM SWIVEL VIDEO (TM) IRRIGATOR
K931398 · KAR
Gm Engineering, Inc.
Ear, Nose, Throat · 164d
Cleared Aug 30, 1993
MAGNETOM P8
K932338 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 30, 1993
PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST
K932921 · DTK
B. Braun Vena-Tech
Cardiovascular · 76d
Cleared Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
K933053 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Aug 30, 1993
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · JWH
Depuy, Inc.
Orthopedic · 54d
Cleared Aug 28, 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · FPA
Baxter Healthcare Corp
General Hospital · 310d
Cleared Aug 27, 1993
TRI-TECH INC. CUSTOM BLOOD ALCOHOL
K922342 · JKA
Tri-Tech, Inc.
Toxicology · 465d
Cleared Aug 27, 1993
N-PAC
K924055 · FYA
National Healthcare Linen Service
General Hospital · 380d
Cleared Aug 27, 1993
I.V. START KIT (AHC-50-54954
K924192 · KGX
American Healthcare Corp.
General & Plastic Surgery · 372d
Cleared Aug 27, 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · KNT
Abbott Laboratories
Gastroenterology & Urology · 344d
Cleared Aug 27, 1993
IV PREP KIT (NON-STERILE)
K925017 · LRS
Customed, Inc.
General & Plastic Surgery · 337d
Cleared Aug 27, 1993
IV PREP KIT W/O DRESSING (NON-STERILE)
K925018 · LRS
Customed, Inc.
General & Plastic Surgery · 337d