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
114745–114768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · LLL
Elias U.S.A., Inc.
Immunology · 70d
Cleared Apr 06, 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · LCX
Syntron Bioresearch, Inc.
Chemistry · 67d
Cleared Apr 05, 1993
DANEKSCOPE AND ACCESSORIES
K911729 · HRX
Danek Medical, Inc.
Orthopedic · 719d
Cleared Apr 05, 1993
ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER
K920595 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 419d
Cleared Apr 05, 1993
TROCARS
K922685 · GCJ
Endoscopic Technologies, Inc.
General & Plastic Surgery · 305d
Cleared Apr 05, 1993
ZEISS VISULAS DIODE LASER
K923274 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 273d
Cleared Apr 05, 1993
ROCHE OXI/FERM II
K923313 · LQM
Roche Diagnostic Systems, Inc.
Microbiology · 272d
Cleared Apr 05, 1993
RISKONTROL SINGLE USE
K923876 · ECB
Riskontrol
Dental · 245d
Cleared Apr 05, 1993
FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER
K924524 · GEI
Valleylab, Inc.
General & Plastic Surgery · 209d
Cleared Apr 05, 1993
TOMEY PROTON TONOMETER
K924760 · HKY
Tomey Corporation USA
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON OPHTHALMIC STAND - MODEL XL3200
K924771 · HMF
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON LENSMETER - MODEL 2021
K924776 · HLM
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
K924777 · HKX
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
K924778 · HKO
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON KERATOMETER - MODLE 2040
K924779 · HJB
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON OPHTHALMIC EXAM UNIT - MODEL 2201
K924780 · HMF
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON PROJECTOR HEAD - MODEL 6000-H
K924784 · HOS
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON RADIUSGAUGE - MODEL 2030
K924785 · HLM
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON LENSMETER
K924788 · HLM
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON AUTO REFRACTOR - MODEL BAR-7
K924790 · HKO
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
POLYP NET
K926104 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 123d
Cleared Apr 05, 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930055 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 89d
Cleared Apr 05, 1993
COULTER RETIC-C CELL CONTROL
K930119 · JPK
Coulter Electronics, Inc.
Hematology · 83d
Cleared Apr 02, 1993
HIP JOINT PROTHESIS
K921400 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 374d