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

Filters: Cleared only ×
175,820 results
133849–133872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1988
BCS NO. 1, BODY CARE SYSTEM
K881800 · IRT
M & A Vertrieb, Liske Und Methling GM
Physical Medicine · 203d
Cleared Nov 16, 1988
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
K883038 · BZR
Bird Products Corp.
Anesthesiology · 120d
Cleared Nov 16, 1988
CEFAR DUAL
K883236 · GZJ
Cefar Medical Products, Inc.
Neurology · 107d
Cleared Nov 16, 1988
MYODAC
K883597 · HCC
Thought Technology , Ltd.
Neurology · 86d
Cleared Nov 16, 1988
GEMINI FEMORAL HIP PROSTHESIS
K883724 · JDI
Depuy, Inc.
Orthopedic · 77d
Cleared Nov 16, 1988
DEXSOL
K883854 · LYX
Northern Scientific, Inc.
Ophthalmic · 64d
Cleared Nov 16, 1988
LA MASSEUSE
K883913 · IRO
Sobel Shipping Co., Inc.
Physical Medicine · 61d
Cleared Nov 16, 1988
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
K884043 · HQE
Grieshaber & Co.
Ophthalmic · 51d
Cleared Nov 16, 1988
PULMANEX TM (NEO-NATAL SIZE)
K884068 · BTM
Life Design Systems, Inc.
Anesthesiology · 78d
Cleared Nov 16, 1988
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105 · CHP
Amersham Corp.
Chemistry · 48d
Cleared Nov 16, 1988
AMOS BOY LIFT CHAIR
K884123 · INO
Howard N. Amos Design & Mfg.
Physical Medicine · 47d
Cleared Nov 16, 1988
ANALYST THEOPHYLLINE CALIBRATOR
K884170 · DLJ
The DU Pont Co.
Toxicology · 56d
Cleared Nov 16, 1988
BECKMAN KAPPA LIGHT CHAIN REAGENT
K884276 · DFH
Beckman Instruments, Inc.
Immunology · 35d
Cleared Nov 16, 1988
MICRO SURGICAL INSTRUMENT SYSTEM
K884492 · HSZ
Tava Surgical Instruments
Orthopedic · 21d
Cleared Nov 16, 1988
RIA/MAT FPA TEST KIT
K884496 · DAN
Altana, Inc.
Immunology · 22d
Cleared Nov 16, 1988
ADULT RESUSCITATOR WITH MASK AND FILTER
K884526 · BTM
Intertech/Ohio
Anesthesiology · 20d
Cleared Nov 15, 1988
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056 · JJC
American Research Products Co.
Chemistry · 249d
Cleared Nov 15, 1988
OLYMPUS GF-UM3/EU-M3
K882061 · GDB
Olympus Corp.
Gastroenterology & Urology · 183d
Cleared Nov 15, 1988
DTL MICROTOUCH EYE ELECTRODE
K882464 · GXY
Lectromedics, Inc.
Neurology · 153d
Cleared Nov 15, 1988
BARD(R) URETERAL STENT W/SUTURE
K883561 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 15, 1988
MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
K883604 · LLZ
Medrad, Inc.
Radiology · 83d
Cleared Nov 15, 1988
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
K883738 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 75d
Cleared Nov 15, 1988
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
K883926 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 61d
Cleared Nov 15, 1988
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
K884360 · HQG
Seiko Corp.
Ophthalmic · 29d