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
82273–82296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
K001485 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 32d
Cleared Jun 13, 2000
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS...
K001584 · LPL
Medvice Consulting, Inc.
Ophthalmic · 22d
Cleared Jun 13, 2000
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR...
K001620 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 19d
Cleared Jun 13, 2000
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
K001762 · DXG
Pulsion Medical Systems, Inc.
Cardiovascular · 4d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...
K992532 · FOZ
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 12, 2000
DORNIER MEDILAS D SKINPULSE
K000072 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 154d
Cleared Jun 12, 2000
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K000687 · GMQ
Beacon Biologicals, Inc.
Microbiology · 104d
Cleared Jun 12, 2000
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
K001252 · IOR
Maxhealth Corp.
Physical Medicine · 54d
Cleared Jun 12, 2000
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
K001284 · HAW
Medtronic Surgical Navigation...
Neurology · 52d
Cleared Jun 12, 2000
EUDERMIC PF POWDER-FREE SURGICAL GLOVES
K001343 · KGO
Maxxim Medical, Inc.
General Hospital · 46d
Cleared Jun 12, 2000
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE...
K001434 · GAT
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 35d
Cleared Jun 12, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING...
K001529 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Jun 12, 2000
PINNACLE ACETABULAR SYSTEM
K001534 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Jun 12, 2000
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
K001549 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jun 12, 2000
3.5 MM LAPAROSCOPE (LG100, LG103)
K001594 · GCJ
Surgical Image Laboratories, Inc.
General & Plastic Surgery · 20d
Cleared Jun 12, 2000
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335 · HTO
Synthes (Usa)
Orthopedic · 252d
Cleared Jun 12, 2000
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3...
K993518 · FOZ
Medefil, Inc.
General Hospital · 238d
Cleared Jun 09, 2000
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
K000336 · NBO
Rhigene, Inc.
Immunology · 127d
Cleared Jun 09, 2000
MULTI ADJUSTABLE FACE MASK
K000358 · DZB
Ortho Technology
Dental · 126d
Cleared Jun 09, 2000
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
K000377 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Jun 09, 2000
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · DPS
Cambridge Heart, Inc.
Cardiovascular · 70d
Cleared Jun 09, 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · EBG
3M Company
Dental · 64d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · DJG
Microgenics Corp.
Toxicology · 59d
Cleared Jun 09, 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · MOS
Usa Instruments, Inc.
Radiology · 56d