Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167761–167784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1980
PROBE
K800729 · HXB
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
RETROGRADE KNIFE
K800730 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
MENISCAL SAW
K800731 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
MENISCOTOME
K800732 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
DOUBLE-EDGE CURETTE
K800733 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 04, 1980
ANTIMICROBIAL REMOVAL DEVICE (ARD)
K800052
Marion Laboratories, Inc.
Microbiology · 86d
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