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
88633–88656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1998
MULTI-STIM TENS, AP-101081T
K973979 · GZJ
Apex Medical Corp.
Neurology · 282d
Cleared Jul 29, 1998
ACU-STIM TENS, AP-101082T
K973980 · GZJ
Apex Medical Corp.
Neurology · 282d
Cleared Jul 29, 1998
QUIDEL CH50 EQ EIA
K974111 · DAE
Quidel Corp.
Immunology · 271d
Cleared Jul 29, 1998
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
K980288 · KWP
Spine-Tech, Inc.
Orthopedic · 184d
Cleared Jul 29, 1998
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES
K980389 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 177d
Cleared Jul 29, 1998
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
K980962 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 135d
Cleared Jul 29, 1998
DISTAL RADIUS FRACTURE FIXATION PLATE
K981715 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Jul 29, 1998
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
K981775 · HRS
Depuy Ace Medical Co.
Orthopedic · 70d
Cleared Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
K981794 · CJY
Hichem Diagnostics
Chemistry · 69d
Cleared Jul 29, 1998
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
K981821 · FSS
Angiolaz, Inc.
General & Plastic Surgery · 68d
Cleared Jul 29, 1998
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
K981856 · FET
Greatbatch Scientific
Gastroenterology & Urology · 63d
Cleared Jul 29, 1998
QUANTA LITE TPO ELISA
K981857 · LLL
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jul 29, 1998
MULTAPORT CANNULA REDUCER AND ACCESSORIES
K981941 · GCJ
Dexide, Inc.
General & Plastic Surgery · 57d
Cleared Jul 29, 1998
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156 · JWJ
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Jul 29, 1998
PROFILE-II MODEL 600582
K982211 · DKE
Medtox Diagnostics, Inc.
Toxicology · 36d
Cleared Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · HWC
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 29, 1998
LUNA
K982351 · OLT
Stellate Systems
Neurology · 23d
Cleared Jul 29, 1998
DOC VENTRAL CERVICAL STABILIZATION SYSTEM
K982443 · KWQ
Depuy Motech Acromed
Orthopedic · 15d
Cleared Jul 28, 1998
MODIFICATION TO THE OXYCONALPHA
K980094 · BTY
Erich Jaeger B.V.
Anesthesiology · 200d
Cleared Jul 28, 1998
MYO-TRAIN V (5)
K980158 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 193d
Cleared Jul 28, 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 85d
Cleared Jul 28, 1998
LIQUID A
K981618 · EMA
Harry J. Bosworth Co.
Dental · 83d
Cleared Jul 28, 1998
INFLUENCE CLIP SYSTEM
K981631 · FZP
Influence, Inc.
General & Plastic Surgery · 82d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K981673 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d