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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143521–143544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · LCX
Quidel Corp.
Chemistry · 7d
Cleared Jun 17, 1986
MICRO THIN* PARAFFIN
K862223 · KEO
Richard-Allan Medical Ind., Inc.
Pathology · 6d
Cleared Jun 16, 1986
DIRECT
K852960 · CGA
University of Wisconsin
Chemistry · 339d
Cleared Jun 16, 1986
ERG 550 ERGOMETER BICYCLE
K854491 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 555 COUCH ERGOMETER
K854493 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
PHYSIO-DYNE ECG/HR 3
K854847 · DRT
Physio-Dyne Industrument Corp.
Cardiovascular · 194d
Cleared Jun 16, 1986
LINEAR SCANNER PROBE, MODEL TL-50
K854959 · IYO
Elscint, Inc.
Radiology · 187d
Cleared Jun 16, 1986
ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS
K860081 · IYO
Elscint, Inc.
Radiology · 159d
Cleared Jun 16, 1986
STORZ, ALPHA II BIOMETRIC RULER
K860553 · ITX
Storz Instrument Co.
Radiology · 122d
Cleared Jun 16, 1986
MATRIX LR, LR 22A & LR/LASER RECORDER
K860776 · LMC
Matrix Instruments
Radiology · 105d
Cleared Jun 16, 1986
SHUR GEL 4
K860855 · ELW
Columbus Dental Mfg. Co.
Dental · 101d
Cleared Jun 16, 1986
COLOPLAST CONVEX RING
K861070 · EXB
Coloplast A/S
Gastroenterology & Urology · 88d
Cleared Jun 16, 1986
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Jun 16, 1986
FLUORO PLUS
K861279 · LLZ
Advantage Medical Systems, Inc.
Radiology · 70d
Cleared Jun 16, 1986
MILEX BARTHOLIN GLAND CATHETER
K861385 · KNA
Milex Products, Inc.
Obstetrics & Gynecology · 63d
Cleared Jun 16, 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541 · BZT
Sheridan Catheter Corp.
Anesthesiology · 53d
Cleared Jun 16, 1986
TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS
K861552 · KNT
Entech, Inc.
Gastroenterology & Urology · 52d
Cleared Jun 16, 1986
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · CAC
American Pharmaseal Div. Ahsc
Anesthesiology · 46d
Cleared Jun 16, 1986
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 34d
Cleared Jun 16, 1986
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855 · JKF
Sterling Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 16, 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946 · LCX
Healthcheck Corp.
Chemistry · 27d
Cleared Jun 16, 1986
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862067 · LFM
American Dade
Toxicology · 17d