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
101353–101376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1995
VALLEYLAB FORCE 300
K953195 · GEI
Valleylab, Inc.
General & Plastic Surgery · 42d
Cleared Aug 21, 1995
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K953289 · DXZ
Davis & Geck, Inc.
Cardiovascular · 38d
Cleared Aug 21, 1995
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET
K953425 · DXZ
Davis & Geck, Inc.
Cardiovascular · 31d
Cleared Aug 21, 1995
KSEA EXTRACTION BAG
K953549 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 24d
Cleared Aug 21, 1995
SPYROFLEX WOUND DRESSING
K953618 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 18d
Cleared Aug 21, 1995
CORSSFIRE PLUS
K953658 · GEX
Cardiogenes
General & Plastic Surgery · 67d
Cleared Aug 18, 1995
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
K934060 · LPH
Howmedica Corp.
Orthopedic · 729d
Cleared Aug 18, 1995
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
K936292 · LPH
Howmedica Corp.
Orthopedic · 610d
Cleared Aug 18, 1995
ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE
K945504 · LYY
Ganz Industries Sdn. Bhd.
General Hospital · 282d
Cleared Aug 18, 1995
ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE
K945505 · KGO
Ganz Industries Sdn. Bhd.
General Hospital · 282d
Cleared Aug 18, 1995
HYPEX(TM) JET INJECTOR
K945873 · KZE
Equidyne Systems, Inc.
General Hospital · 260d
Cleared Aug 18, 1995
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K950009 · JDW
Synvasive Technology, Inc.
Orthopedic · 227d
Cleared Aug 18, 1995
DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES
K950012 · FMI
International Regulatory Consultants
General Hospital · 227d
Cleared Aug 18, 1995
TEC-2110 GREEN LASER MODEL MT-HNG
K950293 · IWE
Medtec, Inc.
Radiology · 205d
Cleared Aug 18, 1995
THERMOCOOL SYSTEM
K950395 · ILO
Zimmer, Inc.
Physical Medicine · 198d
Cleared Aug 18, 1995
R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626
K951274 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595
K951275 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438
K951276 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410
K951277 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284
K951278 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199
K951279 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012
K951280 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035
K951281 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061
K951282 · FLL
R & D Batteries, Inc.
General Hospital · 150d