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
101329–101352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1995
VL7600 REM PATIENT RETURN ELECTRODE
K953737 · GEI
Valleylab, Inc.
General & Plastic Surgery · 13d
Cleared Aug 22, 1995
COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE
K924408 · LYC
Colla-Tec, Inc.
Dental · 1085d
Cleared Aug 22, 1995
HYDROGUM
K935898 · ELW
Zhermack Dental Production
Dental · 679d
Cleared Aug 22, 1995
ULTRASOUND SCANNER 2001
K936024 · IYO
B & K Medical A/S
Radiology · 613d
Cleared Aug 22, 1995
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
K950057 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 229d
Cleared Aug 22, 1995
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
K951594 · OMB
Bio-Logic Systems Corp.
Neurology · 138d
Cleared Aug 22, 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 117d
Cleared Aug 22, 1995
ZEIMER SELF TONOMETER
K953031 · HKX
Cds Technologies
Ophthalmic · 90d
Cleared Aug 22, 1995
Z20
K953047 · ESD
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 22, 1995
Z33
K953050 · ESD
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 21, 1995
SALIVA SAMPLER
K942435 · PJD
Saliva Diagnostic Systems, Inc.
Microbiology · 458d
Cleared Aug 21, 1995
USSC MONOFILAMENT POLYSORB SUTURE
K945285 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 294d
Cleared Aug 21, 1995
USSC POLYSORB SUTURE
K951520 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 140d
Cleared Aug 21, 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION...
K951626 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S),...
K951657 · MNH
Acromed Corp.
Orthopedic · 133d
Cleared Aug 21, 1995
MEDI - PUMP
K951729 · BTA
Thomas Industries
General & Plastic Surgery · 129d
Cleared Aug 21, 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON...
K952270 · DTM
Sorin Biomedical, Inc.
Cardiovascular · 98d
Cleared Aug 21, 1995
OGDEN ANCHOR
K952348 · JDR
American Medical Electronics, Inc.
Orthopedic · 94d
Cleared Aug 21, 1995
PLAYTEX TAMPONS #13695
K952394 · HEB
Playtime Products, Inc.
Obstetrics & Gynecology · 91d
Cleared Aug 21, 1995
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
K952677 · FWP
Porex Surgical, Inc.
General & Plastic Surgery · 70d
Cleared Aug 21, 1995
TRANSIT INFUSION CATHETER
K952874 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 90d
Cleared Aug 21, 1995
EXCALIBUR PLUS ELECTROSURGICAL UNIT
K953007 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 54d
Cleared Aug 21, 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · JDG
Howmedica Corp.
Orthopedic · 52d