Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
67609–67632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · JJY
Bio-Rad
Immunology · 24d
Cleared Nov 05, 2004
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · JPK
Bio-Rad
Hematology · 22d
Cleared Nov 05, 2004
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
K042874 · QEZ
Possis Medical, Inc.
Cardiovascular · 18d
Cleared Nov 05, 2004
K.E.P. CONNECTOR AND CLIP
K042900 · KDJ
K.E.P., LLC
Gastroenterology & Urology · 17d
Cleared Nov 04, 2004
METAL/METAL HIP SYSTEM
K040354 · KWA
Encore Medical, L.P.
Orthopedic · 266d
Cleared Nov 04, 2004
ARTHREX TRIMIT FAMILY
K041189 · HWC
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
K041356 · HWC
Arthrex, Inc.
Orthopedic · 168d
Cleared Nov 04, 2004
POWDERED VINYL PATIENT EXAMINATION GLOVES
K042120 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 90d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210 · MNI
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Nov 04, 2004
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · LPH
Zimmer, Inc.
Orthopedic · 66d
Cleared Nov 04, 2004
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
K042652 · IOR
Taiwan King Strong Co., Ltd.
Physical Medicine · 37d
Cleared Nov 04, 2004
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE...
K042775 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Nov 04, 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL...
K042776 · LPH
Zimmer, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778 · HWC
Linvatec Corp.
Orthopedic · 29d
Cleared Nov 04, 2004
CD HORIZON SPINAL SYSTEM
K042790 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Nov 04, 2004
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
K042798 · KWQ
Interpore Cross Intl.
Orthopedic · 27d
Cleared Nov 04, 2004
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · NJM
Dentsply Intl.
Dental · 14d
Cleared Nov 03, 2004
RANDOX OPIATES ASSAY
K041144 · DJG
Randox Laboratories, Ltd.
Toxicology · 187d
Cleared Nov 03, 2004
'RAPIDTEC 4' TEST
K041712 · DIS
American Bio Medica Corp.
Toxicology · 133d
Cleared Nov 03, 2004
GENICON BIPOLAR FORCEPS MODEL # 600-005-005
K041968 · GEI
Genicon
General & Plastic Surgery · 105d
Cleared Nov 03, 2004
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
K042119 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 89d
Cleared Nov 03, 2004
AQUIFY LENS COMFORT DROPS
K042176 · LPN
Ciba Vision Corporation
Ophthalmic · 84d
Cleared Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307 · JIT
Seradyn, Inc.
Chemistry · 70d
Cleared Nov 03, 2004
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · GWF
Cadwell Laboratories, Inc.
Neurology · 65d