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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112393–112416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1993
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
K930468 · KMF
3M Health Care, Ltd.
General & Plastic Surgery · 190d
Cleared Aug 06, 1993
SANITAS PATIENT SCALE
K930626 · FRW
Dutton-Lainson Co.
General Hospital · 179d
Cleared Aug 06, 1993
AMERICAN POWER CONVERSIONS, BACK-UPS 600
K930791 · FMF
Bio Clinic Co.
General Hospital · 171d
Cleared Aug 06, 1993
REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
K931262 · GCJ
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 151d
Cleared Aug 06, 1993
MEROCEL WOUND DRESSING
K931565 · KMF
Merocel Corp.
General & Plastic Surgery · 129d
Cleared Aug 06, 1993
MEDDRAINS
K931607 · GBN
Armm, Inc.
General & Plastic Surgery · 127d
Cleared Aug 06, 1993
LAPAROSCOPIC BALLOON RETRACTOR
K931649 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 123d
Cleared Aug 06, 1993
ENDOSCOPIC CABLE DRAPE
K931706 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 122d
Cleared Aug 06, 1993
ENDOSCOPIC CABLE/WIRE COVER
K931707 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 122d
Cleared Aug 06, 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034 · EBG
Heraeus Kulzer, Inc.
Dental · 101d
Cleared Aug 06, 1993
OTT SUNGLASSES
K932135 · HQY
Sunnex Fashion Corp.
Ophthalmic · 95d
Cleared Aug 06, 1993
VERRES NEEDLE
K932281 · GCT
Surgeon Surgical Instrumentation, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 06, 1993
PSA ANTIBODY KIT
K932326 · DEH
Ventana Medical Systems, Inc.
Immunology · 100d
Cleared Aug 06, 1993
SUTURE REMOVING FORCEPS
K932385 · GEN
Rocket of London, Ltd.
General & Plastic Surgery · 81d
Cleared Aug 06, 1993
CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM
K932722 · BYH
Carie Med-Tech Services, Inc.
Anesthesiology · 63d
Cleared Aug 06, 1993
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE
K932835 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 57d
Cleared Aug 06, 1993
IMC ENDOSCOPIC INSTRUMENT HOLDER
K933371 · GCS
Inman Medical Corp.
Gastroenterology & Urology · 28d
Cleared Aug 05, 1993
POWDERFREE NATURAL LATEX GLOVES
K921389 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 500d
Cleared Aug 05, 1993
OEM MULTI-VAC POWERED SUCTION PUMP
K924570 · GCX
Oem Medical Div.
General Hospital · 329d
Cleared Aug 05, 1993
SIMULTEST CD3/ANTI-HLA-DR
K924587 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 329d
Cleared Aug 05, 1993
DADE(R) TUMOR MARKER CONTROL
K924919 · JJY
Baxter Diagnostics, Inc.
Immunology · 310d
Cleared Aug 05, 1993
GUIDE-TECH ENCAPSULATED GUIDEWIRE
K926039 · KNY
Cape Tech Medical Products
Gastroenterology & Urology · 247d
Cleared Aug 05, 1993
EYEGLASS FRAMES AND SUNGLASSES
K926065 · HQY
Palm Optical Co., Inc.
Ophthalmic · 247d
Cleared Aug 05, 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 225d