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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128617–128640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1989
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
K894721 · DWE
The Traumafuse Co.
Cardiovascular · 87d
Cleared Oct 20, 1989
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
K895263 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 58d
Cleared Oct 20, 1989
MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT
K895348 · GEX
Lasag Medical Lasers
General & Plastic Surgery · 49d
Cleared Oct 20, 1989
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
K895409 · LEJ
Remington Products Company, LLC
General & Plastic Surgery · 44d
Cleared Oct 20, 1989
MODIFIED ENDOGUIDE
K895559 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Oct 20, 1989
PRIMIDONE (FPIA) KIT
K895567 · LFT
Tudor Laboratories, Inc.
Toxicology · 44d
Cleared Oct 20, 1989
SILICONE INSTRUMENT SHODS
K895591 · GDJ
Key Surgical, Inc.
General & Plastic Surgery · 35d
Cleared Oct 19, 1989
ELECTRO-TOUCH (ET) GLOVE
K890981 · GXY
Psychoenergetic Systems, Inc.
Neurology · 234d
Cleared Oct 19, 1989
BIOLOX CERAMIC BALL
K892644 · LZO
Allo Pro Corp.
Orthopedic · 190d
Cleared Oct 19, 1989
MIP/CT IMAGE PROCESSING WORKSTATION
K892712 · LLZ
Kontron Electronics
Radiology · 188d
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