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
92353–92376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1997
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K971794 · LRK
Frantz Design, Inc.
Dental · 137d
Cleared Sep 29, 1997
SOLITAIRE
K972101 · KLE
Heraeus Kulzer, Inc.
Dental · 117d
Cleared Sep 29, 1997
OPTIVIEW
K972520 · LLZ
Optimed Technologies, Inc.
Radiology · 84d
Cleared Sep 29, 1997
ADVANCE KNEE SYSTEM
K972626 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Sep 29, 1997
KINEMATIC POSITIONERS
K972704 · LNH
Ge Medical Systems, Inc.
Radiology · 73d
Cleared Sep 29, 1997
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
K972731 · KDJ
Klein-Baker Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · ERL
Promex, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957 · FPA
Vlv Associates, Inc.
General Hospital · 49d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN CONTROL
K973099 · JJX
Dade Chemistry Systems, Inc.
Immunology · 41d
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