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
166921–166944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1980
COMPUR M-1000 MINI-PHOTOMETER
K800059 · KHG
Miles Laboratories, Inc.
Hematology · 85d
Cleared Apr 04, 1980
KRYMED LIQUID NITROGEN CRYOJET
K800335 · GEH
Cryomedics, Inc.
General & Plastic Surgery · 50d
Cleared Apr 04, 1980
HEMATO-CHEX
K800361 · JPK
Streck Laboratories, Inc.
Hematology · 44d
Cleared Apr 04, 1980
BACTOGEN-H. INFLUENZAE TYPE B
K800493 · GRO
Armkel, LLC
Microbiology · 31d
Cleared Apr 04, 1980
ADD OF RETICULOCYTE COUNT/CAPABILITIES
K800533 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Apr 04, 1980
3M DISPOSABLE SKIN STAPLER
K800535 · GDT
3M Company
General & Plastic Surgery · 25d
Cleared Apr 04, 1980
CAMPYLOBACTER AGAR W/5-ANTIMICROBICS
K800541 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 25d
Cleared Apr 04, 1980
PARTNER SEVEN DISP. BUBBLE OXYGENATOR
K800555 · DTZ
Cardiovascular Research, Inc.
Cardiovascular · 23d
Cleared Apr 04, 1980
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568 · CFE
Corning Medical & Scientific
Chemistry · 22d
Cleared Apr 04, 1980
TLS TM SURGICAL DRAINAGE SYSTEM
K800581 · GCY
Glasrock Products, Inc.
General & Plastic Surgery · 21d
Cleared Apr 04, 1980
NSI CARBON DIOXIDE REAGENT KIT
K800586 · JFL
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
NSI CALIBRATOR SET
K800588 · JIS
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
GLUCOSE OXIDASE REAGENT
K800589 · CGA
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
BUN KIT
K800590 · CDS
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
VENTRE/SEP CORTISOL RIA
K800594 · CGR
Ventrex Laboratories, Inc.
Chemistry · 18d
Cleared Apr 02, 1980
SHUTRAK
K800132
Moore Business Forms, Inc.
Physical Medicine · 72d
Cleared Apr 02, 1980
MT-10, ET-20
K800251 · IOG
Associated Mills, Inc.
Physical Medicine · 56d
Cleared Apr 02, 1980
OXIDE ANAEROBIC SYSTEM
K800430 · JTM
Oxoid U.S.A., Inc.
Microbiology · 36d
Cleared Apr 02, 1980
NEUROMETRICS MONITOR
K800452 · GWS
Neurometrics
Neurology · 34d
Cleared Apr 02, 1980
ADDITIONAL COMPONENTS KRONNER COMPRES
K800502 · HRS
Richard F. Kronner, M.D.
Orthopedic · 29d
Cleared Apr 02, 1980
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · CIE
Miles Laboratories, Inc.
Chemistry · 27d
Cleared Apr 02, 1980
SCHLEIN TRI-SURFACE ANKLE
K800530 · HSN
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Apr 02, 1980
CINOXACIN 100 MCG SENSI DISC
K800540 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 23d
Cleared Apr 02, 1980
100 ML SNYDER HEMOVAC
K800542 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 23d