FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
15601–15624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2021
AMRA Profiler
K211983 · LNH
Amra Medical AB
Radiology · 152d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 24, 2021
MicroPen EVO
K212558 · QAI
Eclipse Medcorp, LLC
General & Plastic Surgery · 103d
Cleared Nov 24, 2021
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown -...
K212633 · FYC
String King Lacrosse, LLC
General Hospital · 97d
Cleared Nov 24, 2021
Xpert Wrist
K213214 · HRS
Newclip Technics
Orthopedic · 56d
Cleared Nov 24, 2021
ControlRad Select Model Z
K213455 · OWB
Controlrad, Inc.
Radiology · 29d
Cleared Nov 23, 2021
Hystero-V Hysteroscope
K202445 · HIH
Hysterovue, Inc.
Obstetrics & Gynecology · 454d
Cleared Nov 23, 2021
Albumin BCG2
K203248 · CIX
Abbott Ireland Diagnostics Division
Chemistry · 384d
Cleared Nov 23, 2021
Playboy Premium Silicone Lubricant
K210095 · NUC
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 313d
Cleared Nov 23, 2021
Sofia 2 Campylobacter FIA
K211342 · LQP
Quidel Corporation
Microbiology · 204d
Cleared Nov 23, 2021
Uretero1 Ureteroscope System
K211347 · FGB
STERIS Corporation
Gastroenterology & Urology · 204d
Cleared Nov 23, 2021
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387 · BZQ
Sound Life Sciences, Inc.
Anesthesiology · 202d
Cleared Nov 23, 2021
Myomics Q
K211432 · LLZ
Phantomics, Inc.
Radiology · 200d
Cleared Nov 23, 2021
Virtue RF
K211562 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 187d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
039 Surgical Face Mask
K211956 · FXX
Aok Tooling Limited
General Hospital · 152d
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared CT Nov 23, 2021
Exablate Prostate System
K212150 · PLP
InSightec, Inc.
Gastroenterology & Urology · 137d
Cleared Nov 23, 2021
Air compression therapy system FO3002
K212169 · IRP
Foshan Hongfeng Co., Ltd.
Physical Medicine · 134d
Cleared Nov 23, 2021
Hypotension Decision Assist Model HDA-OR2
K212529 · DXG
Directed Systems, Ltd.
Cardiovascular · 104d
Cleared Nov 23, 2021
MZ Skin LightMAX Supercharged LED Mask 2.0
K213184 · OLP
Mz Skin
General & Plastic Surgery · 55d
Cleared Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm,...
K213454 · HBE
Medtronic Powered Surgical Solutions
Neurology · 28d
Cleared Nov 22, 2021
VS3 Iridium Sytem
K210265 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 294d