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
89137–89160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1998
ELECTROSURGICAL BASKET ELECTRODES...
K981589 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 87d
Cleared Jul 30, 1998
SNAP-N-PEEL INTRODUCERS
K981611 · KNY
Circon Corp.
Gastroenterology & Urology · 85d
Cleared Jul 30, 1998
HEPTRAC ELECTRONIC QUALITY CONTROL
K981815 · JPA
Medtronic Blood Management
Hematology · 69d
Cleared Jul 30, 1998
UIBC
K982041 · JMO
Abbott Laboratories
Chemistry · 50d
Cleared Jul 30, 1998
PASCO MIC AND MIC/ID PANELS
K982235 · JTN
Pasco Laboratories, Inc.
Microbiology · 35d
Cleared Jul 30, 1998
DURA-GUARD - DURAL REPAIR PATCH
K982282 · GXQ
Bio-Vascular, Inc.
Neurology · 30d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · LBS
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
K971340 · GWG
Olympus Optical, Co.
Neurology · 475d
Cleared Jul 29, 1998
MICRO II MICROCURRENT TENS
K973978 · GZJ
Apex Medical Corp.
Neurology · 282d
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