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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86857–86880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 20, 1999
ECHO-COAT ULTRASOUND NEEDLES
K983647 · MJG
Sts Biopolymers
General & Plastic Surgery · 96d
Cleared Jan 20, 1999
BIOSONIC ULTRASONIC SCALER SYSTEM
K983727 · ELC
Coltene/Whaledent, Inc.
Dental · 90d
Cleared Jan 20, 1999
MPS GRAVITY FLOW CONTROL SET
K983926 · FPA
Critical Device Corp.
General Hospital · 76d
Cleared Jan 20, 1999
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
K984122 · JQF
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Jan 20, 1999
LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
K984147 · LYY
Lovytex Sdn Bhd
General Hospital · 62d
Cleared Jan 20, 1999
ENLIGHT-2
K984217 · DYH
Sybron Dental Specialties, Inc.
Dental · 57d
Cleared Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331 · HWC
Orthopedic Designs, Inc.
Orthopedic · 48d
Cleared Jan 20, 1999
TIMX LOW BACK SYSTEM
K984348 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 20, 1999
VSP SYSTEM
K984350 · MNI
Depuy Motech Acromed
Orthopedic · 47d