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
137905–137928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1987
POREX NERVE LOCATOR
K872791 · ETN
Porex Medical
Ear, Nose, Throat · 98d
Cleared Oct 20, 1987
ANTINUCLEAR ANTIBODY TEST
K872839 · LJM
Cappel Diagnostics, Inc.
Immunology · 92d
Cleared Oct 20, 1987
ENDOMETRIAL SAMPLER
K872908 · HHK
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K872946 · DHB
Pharmacia, Inc.
Immunology · 84d
Cleared Oct 20, 1987
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · FRN
Imed Corp.
General Hospital · 84d
Cleared Oct 20, 1987
BREAST-SCAN(TM)
K872962 · LHM
Thermascan, Inc.
Radiology · 83d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · FOZ
C.R. Bard, Inc.
General Hospital · 77d
Cleared Oct 20, 1987
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · CGJ
American Dade
Chemistry · 77d
Cleared Oct 20, 1987
OXYGEN ANALYZER MODEL 800 SERIES
K873068 · CCL
Salter Instrumentation, Inc.
Anesthesiology · 75d
Cleared Oct 20, 1987
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074 · JGS
American Monitor Corp.
Chemistry · 75d
Cleared Oct 20, 1987
PHARMACIA IGE EIA
K873077 · JHR
Pharmacia, Inc.
Immunology · 76d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K873112 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · CIJ
Roche Diagnostic Systems, Inc.
Chemistry · 64d
Cleared Oct 20, 1987
BILE ACIDS CONTROLS
K873342 · JJX
Sigma Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 20, 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K873344 · BZT
Medical Components, Inc.
Anesthesiology · 62d
Cleared Oct 20, 1987
SECURLINE FRANSEENE NEEDLE
K873369 · KNW
Precision Dynamics Corp.
Gastroenterology & Urology · 60d
Cleared Oct 20, 1987
TITAN GEL LDH REP SYSTEM
K873386 · CFE
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
HOYER SOLVET
K873395 · CAF
Infrasonics Corp.
Anesthesiology · 57d
Cleared Oct 20, 1987
TITAN GEL CPK REP SYSTEM
K873399 · JHX
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · JLS
Serono Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 20, 1987
BLOCK, BITE, INTUBATION
K873491 · JAY
B&B Medical Technologies, Inc.
Anesthesiology · 50d
Cleared Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · CIJ
Instrumentation Laboratory CO
Chemistry · 48d
Cleared Oct 20, 1987
BAKER TDM THEOPHYLLINE ASSAY
K873596 · KLS
Baker Instructions Corp.
Toxicology · 46d