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
129217–129240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1989
ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
K893394 · CAC
Haemonetics Corp.
Anesthesiology · 171d
Cleared Oct 19, 1989
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · DXK
Toshiba America Medical Systems, In.C
Cardiovascular · 87d
Cleared Oct 19, 1989
SLEEPAP MASK
K894642 · BYG
Medical Industries America, Inc.
Anesthesiology · 87d
Cleared Oct 19, 1989
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
K894667 · BTY
Pneumedics, Inc.
Anesthesiology · 86d
Cleared Oct 19, 1989
QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE
K894854 · KGI
Image Enhancements
Radiology · 80d
Cleared Oct 19, 1989
CLINISTAT LDH REAGENT TEST
K895138 · CFH
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Oct 19, 1989
INTERTECH METERED DOSE ELBOW
K895144 · BZA
Intertech/Ohio
Anesthesiology · 62d
Cleared Oct 19, 1989
ANETHESIA BREATHING CIRCUIT
K895357 · CAI
F.L.W. Plastics, Inc.
Anesthesiology · 52d
Cleared Oct 19, 1989
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395 · GZT
Baxter Healthcare Corp
Neurology · 48d
Cleared Oct 19, 1989
CORTISOL CLASP-BEAD EIA KIT
K895407 · CGR
Biotecx Laboratories, Inc.
Chemistry · 43d
Cleared Oct 19, 1989
SPINAL NEEDLE
K895453 · BSP
Advance Medical Designs, Inc.
Anesthesiology · 44d
Cleared Oct 19, 1989
EXUSORB(TM) GEL DRESSING
K895606 · KMF
Controlled Therapeutics Corp.
General & Plastic Surgery · 31d
Cleared Oct 19, 1989
LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER
K895718 · JGM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Oct 19, 1989
IRRI-EVACUATOR
K895757 · GBX
Mikro-Tek Laboratories
General & Plastic Surgery · 23d
Cleared Oct 19, 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · CDP
Diagnostic Products Corp.
Chemistry · 16d
Cleared Oct 19, 1989
DELTA-TECH(TM) CAST REMOVAL SYSTEM
K895861 · LGH
Johnson & Johnson Professionals, Inc.
Orthopedic · 16d
Cleared Oct 18, 1989
AGAR 3K NEUROMUSCULAR STIMULATOR
K882386 · IPF
Solcoor, Inc.
Physical Medicine · 495d
Cleared Oct 18, 1989
COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
K893962 · LKN
Cobe Laboratories, Inc.
Gastroenterology & Urology · 138d
Cleared Oct 18, 1989
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE
K894071 · DWL
Sara Lee Corp.
General Hospital · 132d
Cleared Oct 18, 1989
2.5 FRENCH LITHOTRIPTOR ELECTRODE
K894704 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 18, 1989
BIOSPOT HCG-RAPID PREGNANCY TEST
K894705 · JHI
Princeton Biomedix
Chemistry · 85d
Cleared Oct 18, 1989
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST
K894750 · JHI
Princeton Biomedix
Chemistry · 84d
Cleared Oct 18, 1989
EN-TRAP SYRINGE
K895203 · FMF
The Medtech Group, Inc.
General Hospital · 61d
Cleared Oct 18, 1989
GENERAL ASPERATOR
K895761 · JCX
Kolster Methods
General & Plastic Surgery · 22d