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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
52201–52224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Sep 25, 2009
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
K091735 · EMA
S & C Polymer GmbH
Dental · 106d
Cleared Sep 25, 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
K091825 · DQX
Abbott Vascular, Inc.
Cardiovascular · 98d
Cleared Sep 25, 2009
ELEGANT
K091826 · EIH
3M Espe AG Dental Products
Dental · 98d
Cleared Sep 25, 2009
NOBELPROCERA ZI ABUTMENT
K091904 · NHA
Nobel Biocare AB
Dental · 92d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX,...
K091946 · MQP
Stryker Spine
Orthopedic · 87d
Cleared Sep 25, 2009
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE)...
K092012 · FXX
Primed Medical Products, Inc.
General Hospital · 81d
Cleared Sep 25, 2009
SPINAL USA INTERBODY CAGES
K092193 · MAX
Spinal USA
Orthopedic · 66d
Cleared Sep 25, 2009
SYNTHES LOCKING HAND PLATES
K092247 · HRS
Synthes (Usa)
Orthopedic · 59d
Cleared Sep 25, 2009
SPI CUSTOMIZABLE GINGIVA FORMER
K092248 · NHA
Thommen Medical AG
Dental · 59d
Cleared Sep 25, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092415 · LYZ
Shijiazhuang Elegance Plastic Product
General Hospital · 50d
Cleared Sep 25, 2009
PASCAL STREAMLINE PHOTOCOAGULATOR
K092621 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 30d
Cleared Sep 25, 2009
FIREBIRD SPINAL FIXATION SYSTEM
K092624 · NKB
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Sep 25, 2009
MODIFICATION TO: EXPEDIUM SPINE SYSTEM
K092626 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Sep 25, 2009
SNM FIRMGRIP
K092629 · FOZ
Flexicath , Ltd.
General Hospital · 29d
Cleared Sep 25, 2009
MANTIS REDUX SPINAL SYSTEM
K092631 · NKB
Stryker Spine
Orthopedic · 30d
Cleared Sep 25, 2009
OSOM INFLUENZA A&B TEST , MODEL PN190
K092633 · PSZ
Genzyme Corporation
Microbiology · 29d
Cleared Sep 25, 2009
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 25, 2009
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
K092683 · DXN
Shanghai Little Doctor Co. Limited
Cardiovascular · 24d
Cleared Sep 24, 2009
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000
K090932 · QEW
Nexgen Medical Systems, Inc.
Cardiovascular · 175d
Cleared Sep 24, 2009
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K091964 · JES
Procter & Gamble Co.
Dental · 85d
Cleared Sep 24, 2009
RP CUTTING NEEDLE
K092059 · KNW
Riverpoint Medical
Gastroenterology & Urology · 79d
Cleared Sep 24, 2009
XIO RTP SYSTEM
K092132 · MUJ
Computerized Medical Systems, Inc.
Radiology · 71d
Cleared Sep 24, 2009
MODIFICATION TO BEACON STABILIZATION SYSTEM
K092610 · NKB
Globus Medical, Inc.
Orthopedic · 30d