FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136585–136608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN SLANT
K880123 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, W/NACL
K880124 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, SELECTIVE
K880125 · JSI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LAURYL TRYPTOSE BROTH
K880126 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, GRUFT
K880131 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIL MEDIUM
K880133 · JSE
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIDDLEBROOK 7H11 AGAR
K880134 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
TRANSRECTAL PROBE BD65S-TR
K880219 · IYO
Elscint, Inc.
Radiology · 71d
Cleared Mar 31, 1988
TRI-STAGE (TS-I) DENTAL IMPLANT
K880220 · DZE
Tri-Stage, Inc.
Dental · 71d
Cleared Mar 31, 1988
'HILT-WAY' RESUSCITATOR
K880241 · CAE
Medifield , Ltd.
Anesthesiology · 71d
Cleared Mar 31, 1988
CHICOPEE ADULT INCONTINENCE SHIELDS
K880338 · EYQ
Chicopee, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 31, 1988
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
K880393 · DYH
Unitek Corp.
Dental · 62d
Cleared Mar 31, 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Mar 31, 1988
MEDICOMP STRAIGHT SWIVEL ADAPTOR
K880434 · BZA
Medicomp, Inc.
Anesthesiology · 59d
Cleared Mar 31, 1988
AERO-MIST NEBULIZER HEATER
K880473 · CAF
Pegasus Research Corp.
Anesthesiology · 56d
Cleared Mar 31, 1988
LAKE DISPOSABLE PROBE COVER
K880578 · FLL
Lake Medical Products, Inc.
General Hospital · 50d
Cleared Mar 31, 1988
EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE
K880596 · HYB
Sigma Chemical Co.
Pathology · 49d
Cleared Mar 31, 1988
UTILITY WAX STRIPS, SPEARMINT
K880607 · EGD
Columbus Dental Mfg. Co.
Dental · 48d
Cleared Mar 31, 1988
PROTEQ SURGEON'S GLOVES
K880632 · KGO
Strategic Materials Group
General Hospital · 44d
Cleared Mar 31, 1988
EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM
K880691 · KIT
Sigma Chemical Co.
Pathology · 38d
Cleared Mar 31, 1988
WHEEL-CHAIR W/MOTOR DRIVE
K880707 · ITI
Paul Weiser Co.
Physical Medicine · 38d
Cleared Mar 31, 1988
ALLERGIST SYRINGES
K880894 · FMF
Abco Dealers, Inc.
General Hospital · 29d
Cleared Mar 31, 1988
CELL-DYN ISOTONIC DILUENT
K881130 · GIF
Abbott Diagnostics
Hematology · 15d
Cleared Mar 30, 1988
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K873360 · KNT
Endovations
Gastroenterology & Urology · 222d