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
81769–81792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 09, 2000
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML,...
K001287 · KPE
Sorenson Medical, Inc.
General Hospital · 46d
Cleared Jun 09, 2000
SYNERGY HEAD/NECK COIL
K001331 · MOS
Philips Medical Systems North...
Radiology · 43d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · FMF
Terumo Medical Corp.
General Hospital · 29d
Cleared Jun 09, 2000
NARKOMED MRI , NM-MRI
K001488 · BSZ
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared Jun 09, 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS...
K001557 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 21d
Cleared Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574 · MID
Axis-Shield
Immunology · 18d
Cleared Jun 09, 2000
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
K993316 · DXN
Ueda Avancer Corp.
Cardiovascular · 249d
Cleared Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · HET
Xomed, Inc.
Obstetrics & Gynecology · 224d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697 · CGZ
Wallac OY
Chemistry · 220d