FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87361–87384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN...
K984317 · LGD
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K984321 · CDD
Ortho-Clinical Diagnostics, Inc.
Immunology · 50d
Cleared Jan 22, 1999
DRAGER OXYLOG 2000
K984577 · CBK
Drager, Inc.
Anesthesiology · 30d
Cleared Jan 21, 1999
LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
K982114 · LYY
M/S Midland Latex Products , Ltd.
General Hospital · 219d
Cleared Jan 21, 1999
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 175d
Cleared Jan 21, 1999
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K982771 · HIH
Gyrus Medical , Ltd.
Obstetrics & Gynecology · 167d
Cleared Jan 21, 1999
OVUM PICK-UP ASPIRATION NEEDLES
K983593 · MQE
Cook Ob/Gyn
Obstetrics & Gynecology · 100d
Cleared Jan 21, 1999
BISURE LAPAROSCOPIC BIPOLAR FORCEPS
K983743 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Jan 21, 1999
MCAS (MODULAR CLIP APPLIER SYSTEM)
K983744 · DSS
Applied Medical Resources
Cardiovascular · 90d
Cleared Jan 21, 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jan 21, 1999
NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
K983828 · LZA
Sinetimed Latex Sdn Bhd
General Hospital · 83d
Cleared Jan 21, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K983998 · LYY
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 73d
Cleared Jan 21, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
K984046 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 70d
Cleared Jan 21, 1999
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM
K984200 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 58d
Cleared Jan 21, 1999
TELEX TINNITUS-COMPANION
K984243 · KLW
Telex Communications, Inc.
Ear, Nose, Throat · 55d
Cleared Jan 21, 1999
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K984259 · LPL
Cl-Tinters
Ophthalmic · 52d
Cleared Jan 21, 1999
ENLIGHT LV
K984362 · DYH
Sybron Dental Specialties, Inc.
Dental · 45d
Cleared Jan 21, 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · KWP
Synthes (Usa)
Orthopedic · 49d
Cleared Jan 21, 1999
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
K990132 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 7d
Cleared Jan 20, 1999
MICOMED - HALM ZIELKE INSTRUMENTATION
K982006 · KWQ
Micomed GmbH
Orthopedic · 226d
Cleared Jan 20, 1999
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · FLE
STERIS Corporation
General Hospital · 202d
Cleared Jan 20, 1999
PARIETEX
K982532 · FTL
Cogent
General & Plastic Surgery · 184d
Cleared Jan 20, 1999
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR...
K982997 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 146d
Cleared Jan 20, 1999
ROWE DUAL-CHECK VALVE
K983217 · FPA
Cook, Inc.
General Hospital · 128d