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
134209–134232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1988
ALM OPERATING TABLES
K884019 · FWX
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 21d
Cleared Oct 13, 1988
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K884032 · GZJ
Morgan Associates, Inc.
Neurology · 20d
Cleared Oct 13, 1988
MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940
K884039 · FWH
Medical Dynamics, Inc.
General & Plastic Surgery · 17d
Cleared Oct 13, 1988
SURGI-TAG(TM) STERILE LABEL SETS
K884055 · LYV
Acacia Laboratories, Inc.
General & Plastic Surgery · 17d
Cleared Oct 13, 1988
LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)
K884073 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 16d
Cleared Oct 13, 1988
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80
K884092 · GEX
Surgilase, Inc.
General & Plastic Surgery · 15d
Cleared Oct 13, 1988
LTDT PATIENT LIFTER
K884110 · ILK
Devine Medical Products
Physical Medicine · 14d
Cleared Oct 13, 1988
CARETEX OR TOWEL
K884112 · KKX
James River Corp.
General Hospital · 14d
Cleared Oct 12, 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · JWH
Howmedica Corp.
Orthopedic · 314d
Cleared Oct 12, 1988
MAXERECT
K881008 · LKY
Kenneth Chapman
Gastroenterology & Urology · 217d
Cleared Oct 12, 1988
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
K881259 · LYE
Triton Biosciences, Inc.
Pathology · 203d
Cleared Oct 12, 1988
DIGITRON STENOSIS PROTOCOL
K881481 · LLZ
Siemens Gammasonics, Inc.
Radiology · 187d
Cleared Oct 12, 1988
100-01778-52 ULTRASOUND SYSTEM
K882478 · IYO
Diasonics, Inc.
Radiology · 118d
Cleared Oct 12, 1988
AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
K882551 · KLA
Intl. Biomedics, Inc.
Gastroenterology & Urology · 113d
Cleared Oct 12, 1988
KOLYNOS DENTAL FLOSS
K882571 · JES
Whitehall Laboratories, Inc.
Dental · 112d
Cleared Oct 12, 1988
MODIFIED BETA QUIK STAT EIA KIT
K882895 · DHA
Pacific Biotech, Inc.
Chemistry · 93d
Cleared Oct 12, 1988
HYDRAMED BY LECHLER
K882953 · CAF
Lechler, Inc.
Anesthesiology · 90d
Cleared Oct 12, 1988
TRACER BONE MILL
K883183 · LYS
De Medica Mfg., Inc.
Orthopedic · 76d
Cleared Oct 12, 1988
TONOMITOR (TM) + SUMP
K883234 · FFT
Tonometrics, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 12, 1988
EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)
K883242 · FMF
Cancer Technologies, Inc.
General Hospital · 71d
Cleared Oct 12, 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 69d
Cleared Oct 12, 1988
MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)
K883416 · JXL
Scott All-Sports, Inc.
Neurology · 58d
Cleared Oct 12, 1988
DENTAL CHAIR
K883437 · KLC
E.F. Brewer Co.
Dental · 58d
Cleared Oct 12, 1988
ORTHO-SEAL
K883465 · DYH
Bisco, Inc.
Dental · 58d