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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13345–13368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2022
Multi-Band Ligator
K213223 · FHN
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 06, 2022
Powder Free Nitrile Gloves
K213448 · LZA
St Future International Limited
General Hospital · 224d
Cleared Jun 06, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K220358 · IYN
GE Medical Systems Ultrasound and...
Radiology · 118d
Cleared Jun 06, 2022
PrimeLOC Attachment System
K220612 · NHA
Innovative Product Brands, Inc.
Dental · 95d
Cleared Jun 06, 2022
Arthrex Knotless AC Repair Devices
K220947 · HTN
Arthrex, Inc.
Orthopedic · 66d
Cleared Jun 06, 2022
Surgical Face Mask (HNFM0304)
K221222 · FXX
Shanghai Hua EN Industrial Co, Ltd.
General Hospital · 40d
Cleared Jun 06, 2022
Drug Relief v1
K221231 · PZR
Dyansys, Inc.
Neurology · 38d
Cleared Jun 06, 2022
Smart Correction System Rings and Compatible HA-Coated Half Pins
K221366 · KTT
Wishbone Medical, Inc.
Orthopedic · 25d
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846 · FPA
Quest Medical, Inc.
General Hospital · 177d
Cleared Jun 03, 2022
SILKRO
K210084 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 507d
Cleared Jun 03, 2022
Portable Oxygen Concentrator, model: P2-E6
K210371 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 480d
Cleared Jun 03, 2022
KLS Martin Neuro Rongeurs
K210741 · HAE
KLS-Martin L.P.
Neurology · 448d
Cleared Jun 03, 2022
eCareManager 4.5
K211046 · MSX
Visicu, Inc.
Cardiovascular · 421d
Cleared Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
K211567 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 378d
Cleared Jun 03, 2022
Multifrax Laser System
K213332 · ONG
Paradigm Medical Corporation
General & Plastic Surgery · 240d
Cleared Jun 03, 2022
Gastric Alimetry System
K213924 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · LON
bioMerieux, Inc.
Microbiology · 169d
Cleared Jun 03, 2022
Atrial Fibrillation History Feature
K213971 · QDB
Apple, Inc.
Cardiovascular · 165d
Cleared Jun 03, 2022
TrueBeam, TrueBeam STx, Edge, VitalBeam
K213977 · IYE
Varian Medical Systems, Inc.
Radiology · 165d
Cleared Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K213988 · LZU
Oasis Medical, Inc.
Ophthalmic · 165d
Cleared Jun 03, 2022
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle,...
K214063 · KNW
Guangzhou Shengwei Medical Devices...
General & Plastic Surgery · 158d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 03, 2022
3D Anatomic Models
K220205 · LLZ
Ricoh USA, Inc.
Radiology · 129d
Cleared Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test...
K220321 · QEP
Hologic, Inc.
Microbiology · 120d