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
86449–86472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1999
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · LYY
Top Glove Sdn. Bhd.
General Hospital · 70d
Cleared Apr 27, 1999
X-TIP INTRAOSSEOUS PERFORATOR
K990511 · DZM
Schiff & Co.
Dental · 68d
Cleared Apr 27, 1999
PILLING WECK SURGICAL Y STENT FORCEPS
K990547 · EOQ
Pilling Weck, Inc.
Ear, Nose, Throat · 64d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · JJY
Bio-Rad
Chemistry · 62d
Cleared Apr 27, 1999
REDI-TEST THC
K990870 · LDJ
Redwood Biotech, Inc.
Toxicology · 42d
Cleared Apr 27, 1999
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH,...
K990947 · GEX
Lumenis, Inc.
General & Plastic Surgery · 36d
Cleared Apr 27, 1999
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971 · JJR
Medica Corp.
Chemistry · 35d
Cleared Apr 27, 1999
MODIFICATION OF: DAVIDSTRIP HCG
K991067 · JHI
Simex Medical, Inc.
Chemistry · 28d
Cleared Apr 27, 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · DDR
Diagnostic Products Corp.
Chemistry · 13d
Cleared Apr 26, 1999
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
K983588 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 195d
Cleared Apr 26, 1999
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
K983776 · HGX
Evenflo Co., Inc.
Obstetrics & Gynecology · 182d
Cleared Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
K990327 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Apr 26, 1999
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K990384 · CAF
Piper Medical Products
Anesthesiology · 77d
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED...
K991151 · HWC
Vilex, Inc.
Orthopedic · 20d
Cleared Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX,...
K991197 · HWC
Vilex, Inc.
Orthopedic · 19d
Cleared Apr 23, 1999
COWBOY XV
K981311 · JOW
Kci New Technologies, Inc.
Cardiovascular · 378d
Cleared Apr 23, 1999
CHALLENGE TEST PACK
K983451 · JOJ
North American Science Assoc., Inc.
General Hospital · 205d
Cleared Apr 23, 1999
SYNTHETIC SERUM SUBSTITUTE (SSS)
K983579 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 192d
Cleared Apr 23, 1999
SIDEKICK INFUSION KIT
K990425 · FRN
I-Flow Corp.
General Hospital · 71d
Cleared Apr 23, 1999
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
K990427 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 71d
Cleared Apr 23, 1999
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · HRX
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
K990485 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
K990486 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K990526 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d