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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95545–95568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1997
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · JDO
Synthes (Usa)
Orthopedic · 76d
Cleared Jan 09, 1997
EYECHEK
K964290 · HLQ
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 73d
Cleared Jan 09, 1997
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
K964321 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 72d
Cleared Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338 · HKM
Rudolf Riester GmbH & Co. KG
Ophthalmic · 70d
Cleared Jan 09, 1997
DAVIS BAYONET ELECTRODES
K964602 · GEI
Valleylab, Inc.
General & Plastic Surgery · 52d
Cleared Jan 09, 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · MGQ
Sage Pharmaceuticals, Inc.
General & Plastic Surgery · 52d
Cleared Jan 09, 1997
SURETEMP
K964643 · FLL
Diatek Instruments, Inc.
General Hospital · 58d
Cleared Jan 09, 1997
LACTATE DEHYDROGENASE
K964912 · CFJ
Derma Media Lab., Inc.
Chemistry · 31d
Cleared Jan 09, 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · JLS
bioMerieux, Inc.
Chemistry · 21d
Cleared Jan 08, 1997
SIRIUS 180, 180L, 230, 230L
K961235 · EFB
Micro-Mega Societe Anonyme
Dental · 285d
Cleared Jan 08, 1997
NON-SHIELDED SURGICAL TROCAR AND SLEEVE
K963760 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 112d
Cleared Jan 08, 1997
LSI VIDEOSCOPIC DISPLAY SYSTEM
K963919 · GCJ
Lsi Solutions
General & Plastic Surgery · 100d
Cleared Jan 08, 1997
LASERSCOPE ERBIUM
K964076 · GEX
Laserscope
General & Plastic Surgery · 89d
Cleared Jan 08, 1997
LORI HEARING AID SIMULATOR
K964080 · KHL
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 89d
Cleared Jan 08, 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · DSI
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Jan 08, 1997
PERFECTA PLASMA SPRAY HIP STEM
K964218 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 78d
Cleared Jan 08, 1997
DURA-BOARD ARMBOARD
K964273 · GDC
Allen Medical Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jan 08, 1997
DEGANIA SILICONE INDENTI LOOPS
K964547 · DXC
Degania Silicone , Ltd.
Cardiovascular · 56d
Cleared Jan 08, 1997
CELL RECOVERY SYSTEM
K965037 · FDX
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 07, 1997
CPR BIO-BARRIER FACESHEILD
K960995 · CBP
O-Two Systems Intl., Inc.
Anesthesiology · 301d
Cleared Jan 07, 1997
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
K962585 · FNM
United Medical Equipment, Inc.
General Hospital · 190d
Cleared Jan 07, 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · DYB
Johnson & Johnson Medical, Inc.
Cardiovascular · 160d
Cleared Jan 07, 1997
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
K963620 · FNM
9th Wave, Inc.
General Hospital · 119d
Cleared Jan 07, 1997
VERSATEC 310 ELECTRODE
K963975 · DRX
Versatec, Inc.
Cardiovascular · 96d