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
82657–82680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2000
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT...
K000691 · HRX
Oratec Interventions, Inc.
Orthopedic · 65d
Cleared May 04, 2000
DIRECT TIBC CALIBRATOR
K000783 · JIT
Reference Diagnostics, Inc.
Chemistry · 55d
Cleared May 04, 2000
KAVO K.E.Y. LASER 1242
K000805 · GEX
Kavo America
General & Plastic Surgery · 52d
Cleared May 04, 2000
SHARP BRAND ACUPUNCTURE NEEDLES
K000816 · MQX
Tcm Supply Corp.
General Hospital · 52d
Cleared May 04, 2000
HTF-HEPES
K000939 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 42d
Cleared May 04, 2000
HUMAN SERUM ALBUMIN (HSA)
K000940 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 42d
Cleared May 04, 2000
MULTI-PULSE 2000
K001248 · EHD
Imaging Sciences Intl., Inc.
Radiology · 16d
Cleared May 04, 2000
SIMPLEX AIRBRATOR (SAB-7)
K980672 · KOJ
Irt Management Corp.
Dental · 804d
Cleared May 04, 2000
MEDI-CULT FLUSHING MEDIUM
K991327 · MQL
Medicult A/S
Obstetrics & Gynecology · 381d
Cleared May 04, 2000
MEDI-CULT SPERM PREPARATION - MEDIUM
K991332 · MQL
Medicult A/S
Obstetrics & Gynecology · 381d
Cleared May 04, 2000
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
K992592 · KFM
A-Med Systems, Inc.
Cardiovascular · 276d
Cleared May 04, 2000
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD...
K993816 · MCW
Baxter Edwards
Cardiovascular · 176d
Cleared May 04, 2000
CEMSTOP CEMENT RESTRICTOR
K993841 · LZN
Encore Orthopedics, Inc.
Orthopedic · 174d
Cleared May 04, 2000
MODULAR-PLUS REVISION STEM
K994126 · LWJ
Plus Orthopedics
Orthopedic · 149d
Cleared May 03, 2000
CLINI-DENT
K000140 · MAU
The Precident Group
Dental · 106d
Cleared May 03, 2000
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED...
K000333 · JOS
Triad Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 03, 2000
COLORADO MICRODISSECTION NEEDLE
K000348 · GEI
Stryker Leibinger
General & Plastic Surgery · 90d
Cleared May 03, 2000
MOTORIZED MICRO MULTILEAF COLLIMATOR
K000349 · IXI
Stryker Leibinger
Radiology · 90d
Cleared May 03, 2000
FOTOMASTER
K000380 · LLZ
Hamilton Thorne Research
Radiology · 86d
Cleared May 03, 2000
EINSTEIN PROCESSING AND REVIEW WORKSTATION
K000395 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 86d
Cleared May 03, 2000
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
K000438 · FMF
Biosurgical Corp.
General Hospital · 83d
Cleared May 03, 2000
ATR TECNIKA
K000547 · EFB
Advanced Technology Research (A.T.R.)...
Dental · 75d
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · DQO
Cordis Corp.
Cardiovascular · 71d
Cleared May 03, 2000
AU5, AU6
K000681 · IYO
Biosound Esaote, Inc.
Radiology · 65d