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
91849–91872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
K973100 · JIT
Dade Chemistry Systems, Inc.
Immunology · 41d
Cleared Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186 · DHB
Diagnostic Products Corp.
Immunology · 35d
Cleared Sep 29, 1997
RETINOL BINDING PROTEIN RBP RID KIT
K973189 · CZS
The Binding Site, Ltd.
Immunology · 35d
Cleared Sep 29, 1997
JIMMY JOHN III RECTAL NOZZLE
K973256 · KPL
Colon Therapeutics
Gastroenterology & Urology · 35d
Cleared Sep 29, 1997
XOMED T-STENT, FRONTAL SINUS STENT
K973273 · KAM
Xomed, Inc.
General & Plastic Surgery · 27d
Cleared Sep 29, 1997
ENT IRRIGATING PUMP (70327700)
K973286 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 27d
Cleared Sep 29, 1997
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · JJW
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared Sep 26, 1997
3M LITTMANN ELECTRONIC STETHOSCOPE
K961848 · DQD
Minnesota Mining and Mfg. Co.
Cardiovascular · 501d
Cleared Sep 26, 1997
SPORTROL RAPID STERILITY INDICATOR
K962649 · MTC
North American Science Assoc., Inc.
General Hospital · 445d
Cleared Sep 26, 1997
SANPO I
K964541 · NFB
Koike Medical Co.
Anesthesiology · 329d
Cleared Sep 26, 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · LZA
Influx Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Sep 26, 1997
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
K970253 · KDI
Gambro Healthcare
Gastroenterology & Urology · 247d
Cleared Sep 26, 1997
POCKET RESCUE
K970688 · KGB
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 213d
Cleared Sep 26, 1997
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
K970937 · GCJ
Mist, Inc.
General & Plastic Surgery · 197d
Cleared Sep 26, 1997
RAPPORT V.T.D.
K971443 · LKY
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d
Cleared Sep 26, 1997
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K971808 · CAF
Monarch Medical
Anesthesiology · 134d
Cleared Sep 26, 1997
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT...
K971979 · HIB
Playtex Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Sep 26, 1997
ACS VIKING GUIDING CATHETER
K972484 · DQY
Guidant Corp.
Cardiovascular · 86d
Cleared Sep 26, 1997
EMG RETRAINER
K972487 · HCC
Chattanooga Group, Inc.
Neurology · 86d
Cleared Sep 26, 1997
KERR NEXUS ONE BOTTLE ADHESIVE
K972858 · KLE
Sybron Dental Specialties, Inc.
Dental · 53d
Cleared Sep 26, 1997
ASLI
K973473 · IOR
Texin Industrial (International) , Ltd.
Physical Medicine · 11d
Cleared Sep 25, 1997
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · KDL
Cobe Renal Care, Inc.
Gastroenterology & Urology · 664d
Cleared Sep 25, 1997
W.M.E. GPS 1001
K961751 · IPF
Weaver Medical Electronics, Inc.
Physical Medicine · 507d