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
150649–150672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1984
PYRO-TIP
K841591 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 196d
Cleared Oct 31, 1984
ND-YAG LASER 8000 NEUROSURGERY APPLICA
K842703 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 112d
Cleared Oct 31, 1984
CONCEPT C-VAC
K842710 · GCY
Concept, Inc.
General & Plastic Surgery · 111d
Cleared Oct 31, 1984
CANNULA
K843187 · GEA
Ethicon, Inc.
General & Plastic Surgery · 79d
Cleared Oct 31, 1984
UVA SUNTANNING UNITS VARIOUS MODELS
K843306 · FTC
Topsolo Sun Systems
General & Plastic Surgery · 69d
Cleared Oct 31, 1984
AUTOMATIC MULTICLIP DISPOS. LIGATING
K843336 · FZP
Davis & Geck, Inc.
General & Plastic Surgery · 65d
Cleared Oct 31, 1984
NISONSON WIRE & DRILL GUIDE SYS
K843348
Stryker Corp.
General & Plastic Surgery · 65d
Cleared Oct 31, 1984
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
K843360 · CBT
Analytical Products, Inc.
Hematology · 64d
Cleared Oct 31, 1984
PHARMA-PLAST SYRINGE
K843471 · FMF
Zimmar Consulting , Ltd.
General Hospital · 55d
Cleared Oct 31, 1984
PHARMA-PLAST SYRINGE WITH NEEDLE
K843472 · FMF
Zimmar Consulting , Ltd.
General Hospital · 55d
Cleared Oct 31, 1984
PHARMA-PLAST INSULIN SYRINGE
K843473 · FMF
Zimmar Consulting , Ltd.
General Hospital · 55d
Cleared Oct 31, 1984
PHARMA-PLAST SINGLE USE OVERSHOES
K843475 · FXP
Zimmar Consulting , Ltd.
General Hospital · 55d
Cleared Oct 31, 1984
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · KKX
Busse Hospital Disposables, Inc.
General Hospital · 55d
Cleared Oct 31, 1984
SURGICAL KNIVES & PROBES
K843497 · EMF
Eder Instrument Co, Inc.
General & Plastic Surgery · 55d
Cleared Oct 31, 1984
ARTHROSCOPY LEG HOLDER
K843499
Eder Instrument Co, Inc.
General & Plastic Surgery · 55d
Cleared Oct 31, 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · FRN
Intermedics, Inc.
General Hospital · 51d
Cleared Oct 31, 1984
MSI SURGI-GRADE SUTURE TRAY
K843564 · FSM
Medical Sterilization, Inc.
General & Plastic Surgery · 51d
Cleared Oct 31, 1984
ULTRAXLONE ECL-01-1000 CELL LINE
K843577 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
ULTRACLONE ECL-01-2100 CELL LINE
K843578 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
ULTRACLONE ECL-01-1100
K843579 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Oct 31, 1984
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
K843613 · GMS
Immuno-Products Industries
Immunology · 51d
Cleared Oct 31, 1984
AVI GUARDIAN MICRO 410 INFUSION PUMP
K843615 · FRN
Avi, Inc.
General Hospital · 47d
Cleared Oct 31, 1984
AVI GUARDIAN 400 INFUSION PUMP
K843616 · FRN
Avi, Inc.
General Hospital · 47d