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
100201–100224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1995
FINESSE LOW-FUSING PORCELAIN SYSTEM
K954761 · EIH
Dentsply Intl.
Dental · 16d
Cleared Nov 02, 1995
NEXUS
K954762 · EMA
Sybron Dental Specialties, Inc.
Dental · 16d
Cleared Nov 02, 1995
LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM
K954871 · GEI
Conmedcorp
General & Plastic Surgery · 9d
Cleared Nov 01, 1995
UNSCENTED MENSTRUAL PAD
K953633 · HHD
Tendasoft, Inc.
Obstetrics & Gynecology · 89d
Cleared Nov 01, 1995
UNSCENTED CURVED ULTRATHIN MAXI PADS
K953667 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 86d
Cleared Nov 01, 1995
UNSCENTED ULTRATHIN MAXI PAD
K953668 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 86d
Cleared Nov 01, 1995
PRECLUDE DURA SUBSTITUTE
K953969 · GXQ
W.L. Gore & Associates, Inc.
Neurology · 71d
Cleared Nov 01, 1995
TOURNI-COMP
K954103 · KCY
Scandinavian Medical JW AB
General & Plastic Surgery · 62d
Cleared Nov 01, 1995
STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS
K954253 · GEI
Storz Instrument Co.
General & Plastic Surgery · 51d
Cleared Nov 01, 1995
VIROTROL IV
K954298 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 48d
Cleared Nov 01, 1995
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · MGQ
Derma Sciences, Inc.
General & Plastic Surgery · 22d
Cleared Nov 01, 1995
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · MGQ
Derma Sciences, Inc.
General & Plastic Surgery · 16d
Cleared Oct 31, 1995
MITEK MINI ANCHOR
K936311 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 559d
Cleared Oct 31, 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 503d
Cleared Oct 31, 1995
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
K950003 · DXH
Instromedix, Inc.
Cardiovascular · 301d
Cleared Oct 31, 1995
ANALYST, MODEL DSP 300
K950760 · DQD
Heart Sounds, Inc.
Cardiovascular · 256d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 1
K951039 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 2
K951040 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 3
K951041 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 31, 1995
PEBA ANCHOR (MULTIPLE SIZES)
K951451 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 216d
Cleared Oct 31, 1995
IMAGYN HYSTEROSCOPE SHEATHS
K952032 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 183d
Cleared Oct 31, 1995
SUPERSLICK
K952700 · JOH
Bivona Medical Technologies
Anesthesiology · 140d
Cleared Oct 31, 1995
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
K952985 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
WIDE SCREW HA-5B, CYL-HA-5
K952991 · DZE
Implant Center of the Palm Beaches
Dental · 130d