FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113593–113616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1993
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
K931227 · KZR
U.S. Drug Testing, Inc.
Toxicology · 57d
Cleared May 05, 1993
WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
K915525 · JWH
Dow Corning Wright
Orthopedic · 512d
Cleared May 05, 1993
ACUFEX PASSING PINS AND SURGICAL WIRE
K920621 · HWQ
Acufex Microsurgical, Inc.
Orthopedic · 449d
Cleared May 05, 1993
POLY INSERT 20 DEGREE
K920929 · JDL
Dow Corning Wright
Orthopedic · 432d
Cleared May 05, 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
K920968 · LZO
Dow Corning Wright
Orthopedic · 429d
Cleared May 05, 1993
HYDROXYLAPATITE INFINITY(R)
K920969 · MEH
Dow Corning Wright
Orthopedic · 429d
Cleared May 05, 1993
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
K921319 · GZB
Neuromed, Inc.
Neurology · 412d
Cleared May 05, 1993
SOFT TISSUE EXPANDER
K923381 · HWQ
Acufex Microsurgical, Inc.
Orthopedic · 300d
Cleared May 05, 1993
THE HERBST APPLIANCE
K923405 · EJF
Ormco Corp.
Dental · 299d
Cleared May 05, 1993
PHILIPS LASER DISK ARCHIVE
K923481 · LMC
Philips Medical Systems, Inc.
Radiology · 294d
Cleared May 05, 1993
NASAL CAVITY WOUND DRESSING
K923957 · KMF
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 272d
Cleared May 05, 1993
AUTOMATIC CALORIC IRRIGATION SYSTEM
K925237 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 201d
Cleared May 05, 1993
ACUFEX T-BAR
K925573 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 183d
Cleared May 05, 1993
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
K926033 · ELW
Harry J. Bosworth Co.
Dental · 155d
Cleared May 05, 1993
ACUFEX SUTURE RETRIEVER
K926036 · GAE
Acufex Microsurgical, Inc.
General & Plastic Surgery · 155d
Cleared May 05, 1993
HARPOON SUTURE ANCHOR
K926037 · JDR
Biomet, Inc.
Orthopedic · 155d
Cleared May 05, 1993
NUGOLD 2%
K926145 · EJS
Jeneric/Pentron, Inc.
Dental · 149d
Cleared May 05, 1993
BEL-AIR VENTILATION TUBE
K926462 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 132d
Cleared May 05, 1993
IN-THE-EAR HEARING AID
K931023 · ESD
Hearing Improvement
Ear, Nose, Throat · 65d
Cleared May 05, 1993
RIONET HEARING AID HB-53W
K931320 · ESD
Rion Co. Ltd. Dba Rion Acoustic Device
Ear, Nose, Throat · 50d
Cleared May 03, 1993
INSTRUMENTARIUM MEGA4 HT
K923581 · LNH
Instrumentarium Imaging, Inc.
Radiology · 287d
Cleared May 03, 1993
INSTRUMENTARIUM MEGA4 HT
K924472 · LNH
Instrumentarium Imaging, Inc.
Radiology · 243d
Cleared May 03, 1993
PC TELERADIOLOGY(TM)
K925050 · LMD
Arizona State Radiology
Radiology · 209d
Cleared May 03, 1993
SOLSTAR BRILLENMODE SPECTACLE FRAMES
K930561 · HQZ
Solstar Produktions GmbH
Ophthalmic · 89d