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
118489–118512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1992
SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM
K914919 · GCJ
Smith & Nephew Dyonics, Inc.
General & Plastic Surgery · 66d
Cleared Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · KRH
Baxter Healthcare Corp
Cardiovascular · 64d
Cleared Jan 09, 1992
MED-EQUIP CORPORATION
K915076 · ESD
Medequip Co.
Ear, Nose, Throat · 62d
Cleared Jan 09, 1992
712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · FQO
Midmark Corp.
General & Plastic Surgery · 57d
Cleared Jan 09, 1992
REMOVE ADHESIVE REMOVER
K915150 · KOX
Smith & Nephew United, Inc.
General & Plastic Surgery · 56d
Cleared Jan 09, 1992
RANGEROLLER
K915152 · ITI
Excel Mobility Products, Inc.
Physical Medicine · 56d
Cleared Jan 09, 1992
ARTHROSCOPY CAMERA DRAPE
K915214 · KKX
O.R. Concepts, Inc.
General Hospital · 52d
Cleared Jan 09, 1992
GEN-X 800/500
K915227 · IZO
Swiss Ray Medical Systems
Radiology · 50d
Cleared Jan 09, 1992
GRUNDIG ELECTRONICS VARIOUS MODELS
K915232 · IZI
Perkins Mfg. Co.
Radiology · 48d
Cleared Jan 09, 1992
PHILIPS PCR-ACE SYSTEM
K915237 · LLZ
Philips Medical Systems, Inc.
Radiology · 48d
Cleared Jan 09, 1992
RIONET HEARING AID HB-52AS
K915319 · ESD
Rion Co. Ltd. Dba Rion Acoustic Device
Ear, Nose, Throat · 48d
Cleared Jan 09, 1992
GEN-X 800/300
K915339 · IZO
Swissray Finatech, Inc.
Radiology · 50d
Cleared Jan 09, 1992
SONOTONE BODY AID MODEL ST 1000 BODY WORN
K915517 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 49
K915518 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 53A
K915519 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
CUSHION, WHELCHAR AND FLOTATION
K915629 · KNN
Invacare Corp.
Physical Medicine · 23d
Cleared Jan 09, 1992
BIODEX SYSTEM 2 AUTOPROGRAM
K915648 · IKK
Biodex Corp.
Physical Medicine · 27d
Cleared Jan 09, 1992
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
K915683 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 09, 1992
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
K915684 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 08, 1992
HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300
K911615 · DQK
Diagnostic Monitoring Software
Cardiovascular · 272d
Cleared Jan 08, 1992
INTERPORE HEX HEAD IMPLANT RESTORATIVE COMPONENTS
K912734 · DZE
Interpore Intl.
Dental · 202d
Cleared Jan 08, 1992
HORIZON PACEMAKER DETECTION SOFTWARE
K913339 · DSI
Mennen Medical, Inc.
Cardiovascular · 166d
Cleared Jan 08, 1992
PAM PLUS
K913998 · IRO
Kinetic Concepts, Inc.
Physical Medicine · 124d
Cleared Jan 08, 1992
ST5500 UNIVERSAL CARE STRETCHER
K914543 · FPO
Lic Care, Inc.
General Hospital · 90d