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
108409–108432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1994
EPTFE SHEET COVERING FOR OCULAR IMPLANT
K934834 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 209d
Cleared May 05, 1994
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS
K934916 · GCJ
Conmedcorp
General & Plastic Surgery · 203d
Cleared May 05, 1994
JO-1 EIA TEST KIT
K935417 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
SCL-70 EIA TEST KIT
K935418 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
LA EIA TEST KIT
K935419 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
K935531 · GBX
Puritas Health Care, Inc.
General & Plastic Surgery · 170d
Cleared May 05, 1994
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
K935590 · JOQ
Ep Medical, Inc.
Cardiovascular · 168d
Cleared May 05, 1994
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · GQH
Light Diagnostics
Microbiology · 154d
Cleared May 05, 1994
TYMPOVENT
K936275 · ETD
Atos Medical AB
Ear, Nose, Throat · 126d
Cleared May 05, 1994
STRYKER OPERATING ROOM TABLE
K940068 · FQO
Stryker Medical
General & Plastic Surgery · 119d
Cleared May 05, 1994
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15
K940514 · LNH
Medical Advances, Inc.
Radiology · 90d
Cleared May 05, 1994
MONOPOLAR SURGICAL INSTRUMENTS
K940552 · GEI
Tnco, Inc.
General & Plastic Surgery · 87d
Cleared May 05, 1994
CONTROL-A-FLO(TM) REGULATOR
K940867 · FPA
Baxter Healthcare Corp
General Hospital · 71d
Cleared May 05, 1994
GEL CUSHION
K941858 · KIC
Hollister, Inc.
Physical Medicine · 20d
Cleared May 04, 1994
WHITE RIVER MANUAL BREAST PUMP
K925738 · HGY
White River (Tm)
Obstetrics & Gynecology · 537d
Cleared May 04, 1994
520 DISPLAY DRIVER- STATUS I
K926298 · DRT
Vidco, Inc.
Cardiovascular · 506d
Cleared May 04, 1994
LEEP AND LLETZ ELECTRODES
K930132 · HGI
Nordex Medical Corp.
Obstetrics & Gynecology · 477d
Cleared May 04, 1994
AMSET(TM) CANNULATED BONE SCREW
K931538 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 401d
Cleared May 04, 1994
CANNULATED CANCELLOUS SCREW
K931680 · HWC
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
EPIPHYSIS PLATE
K931684 · HRS
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
T-PLATE
K931692 · HRS
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K932202 · GZB
Medtronic Vascular
Neurology · 363d
Cleared May 04, 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · KWP
Danek Medical, Inc.
Orthopedic · 307d
Cleared May 04, 1994
CARRASYN ORAL WOUND DRESSING
K933741 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 274d