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
82297–82320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2000
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML,...
K001287 · KPE
Sorenson Medical, Inc.
General Hospital · 46d
Cleared Jun 09, 2000
SYNERGY HEAD/NECK COIL
K001331 · MOS
Philips Medical Systems North...
Radiology · 43d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · FMF
Terumo Medical Corp.
General Hospital · 29d
Cleared Jun 09, 2000
NARKOMED MRI , NM-MRI
K001488 · BSZ
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared Jun 09, 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS...
K001557 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 21d
Cleared Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574 · MID
Axis-Shield
Immunology · 18d
Cleared Jun 09, 2000
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
K993316 · DXN
Ueda Avancer Corp.
Cardiovascular · 249d
Cleared Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · HET
Xomed, Inc.
Obstetrics & Gynecology · 224d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697 · CGZ
Wallac OY
Chemistry · 220d
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701 · KXK
Syncor International, Inc.
Radiology · 220d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR...
K994199 · KKX
Custom Medical Products, Inc.
General Hospital · 179d
Cleared Jun 08, 2000
UNIVEC TWO PIECE SYRINGE
K000747 · FMF
Univec, Inc.
General Hospital · 93d
Cleared Jun 08, 2000
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX,...
K000792 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815 · MHX
Datex-Ohmeda
Cardiovascular · 87d
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 87d
Cleared Jun 08, 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · JEY
Bionx Implants, Inc.
Dental · 86d
Cleared Jun 08, 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 08, 2000
PENADAPT 10
K000904 · FYD
Buffalo Filter Co., Inc.
General Hospital · 79d
Cleared Jun 08, 2000
AU5 ULTRASOUND IMAGING SYSTEM
K000931 · IYN
Biosound Esaote, Inc.
Radiology · 78d
Cleared Jun 08, 2000
SPERM WASH MEDIUM, CAT# 2003/2005
K000989 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 72d
Cleared Jun 08, 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · KWS
Biopro, Inc.
Orthopedic · 69d
Cleared Jun 08, 2000
L720 EXAMINATION CHAIR
K001261 · KNC
Luneau Gynecologie SA
Obstetrics & Gynecology · 50d