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
108337–108360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1994
JR. MICROCOAGULATION SYSTEM
K940401 · JPA
International Technidyne Corp.
Hematology · 104d
Cleared May 11, 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · LLL
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 11, 1994
THORA-CATH
K941232 · JOL
Gesco Intl., Inc.
General Hospital · 57d
Cleared May 11, 1994
THYROGLOBULIN EIA TEST KIT
K941358 · JNL
Immunoprobe, Inc.
Immunology · 51d
Cleared May 11, 1994
MICROSOMAL EIA TEST KIT
K941361 · JNL
Immunoprobe, Inc.
Immunology · 51d
Cleared May 11, 1994
ACTION AT MANUAL WHEELCHAIR
K941989 · IOR
Nvacare Corp.
Physical Medicine · 16d
Cleared May 10, 1994
LIFETEK IUI CATHETER
K921518 · MFD
Lifetek Medical, Inc.
Obstetrics & Gynecology · 770d
Cleared May 10, 1994
CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575
K921727 · KNF
Viggo-Spectramed
Obstetrics & Gynecology · 760d
Cleared May 10, 1994
DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
K931474 · KDW
Gbf Medical Group
Chemistry · 412d
Cleared May 10, 1994
LIGHTWRITER
K931855 · ILQ
Zygo Corp.
Physical Medicine · 392d
Cleared May 10, 1994
MAGNUM
K932902 · BZQ
Sps, Inc.
Anesthesiology · 329d
Cleared May 10, 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 264d
Cleared May 10, 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 258d
Cleared May 10, 1994
MODEL 222 CLINICAL AUDIOMETER
K934715 · EWO
Virtual Corp.
Ear, Nose, Throat · 221d
Cleared May 10, 1994
QUADRATURE SMALL EXTREMITY COIL
K935015 · LNH
Magnetic Research, Inc.
Radiology · 203d
Cleared May 10, 1994
TRACHEAL SUCTION CATHETER
K935600 · BSY
Puritas Health Care, Inc.
Anesthesiology · 172d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · LXB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d
Cleared May 10, 1994
AFFINITY VENOUS RESERVIOR BAG
K935717 · DTN
Avecor Cardiovascular, Inc.
Cardiovascular · 161d
Cleared May 10, 1994
GLUCOFILM TEST STRIPS
K936212 · CGA
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared May 10, 1994
HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION
K940462 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 97d
Cleared May 10, 1994
SCOPEJOCKEY
K940780 · OCU
Fibertech Instruments, Inc.
Gastroenterology & Urology · 77d
Cleared May 10, 1994
I-STAT 200 PORTABLE CLINICAL ANALYZER
K940918 · CHL
I-Stat Corp.
Chemistry · 74d
Cleared May 10, 1994
INSUFFLATION TUBING & FILTER
K941094 · HET
H & C Chemical, Inc.
Obstetrics & Gynecology · 63d
Cleared May 10, 1994
UORCAP,MODEL NUMBER UDS-UCAP
K941105 · EXY
Laborie Medical Tech, Inc.
Gastroenterology & Urology · 64d