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
133633–133656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 12, 1988
LAKE FOLEY CATHETERIZATION TRAY
K883610 · FCN
Lake Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 12, 1988
STERILE SURGEONS GLOVES
K883736 · KGO
Medical Manufacturers Marketing Co.
General Hospital · 41d
Cleared Oct 12, 1988
ALBABOND 60
K883758 · EJT
Degussa Dental, Inc.
Dental · 36d
Cleared Oct 12, 1988
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
K883792 · JIY
Catachem, Inc.
Chemistry · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 27d
Cleared Oct 12, 1988
KVM ISOTONIC FLUSH SOLUTION
K883989 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM ISOTONIC DILUENT
K883990 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM HEMOGLOBIN LYSING REAGENT
K883991 · GGK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM PREPACK HEMATOLOGY REAGENT SET
K883992 · GKK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
X-ACT UREA/TDA
K883995 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
X-ACT LDC/IND
K883996 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999 · GTZ
Quidel Corp.
Microbiology · 23d