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
89617–89640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1998
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · GMZ
Alexon - Trend, Inc.
Microbiology · 72d
Cleared Apr 23, 1998
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
K980516 · KGO
London International Group, Inc.
General Hospital · 72d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL
Diamedix Corp.
Immunology · 55d
Cleared Apr 23, 1998
POWDER FREE CHLORINATED GLOVES-(TEXTURED)
K981164 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 23d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278 · JJX
Roche Diagnostics GmbH
Chemistry · 15d
Cleared Apr 22, 1998
MICROKERATOME OR THE MATE
K974598 · HNO
Howard Instruments, Inc.
Ophthalmic · 134d
Cleared Apr 22, 1998
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K980634 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 62d
Cleared Apr 22, 1998
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Apr 22, 1998
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · IYO
Boston Scientific Corp
Radiology · 48d
Cleared Apr 22, 1998
MAICO MA53
K981142 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 22, 1998
MANAN MANTA CATHETER FIXATION DISK
K981229 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 22, 1998
MANAN MALECOT BASKET DRAINAGE CATHETER
K981258 · FEW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 22, 1998
DUAL LUER LOCK CAP
K981318 · FPA
Baxter Healthcare Corp
General Hospital · 12d
Cleared Apr 21, 1998
DETACHABLE SILICONE BALLOON (DSB)
K964488 · MZQ
Target Therapeutics
Neurology · 529d
Cleared Apr 21, 1998
DETACHABLE SLICONE BALLOON (DSB)
K965071 · MZQ
Target Therapeutics
Neurology · 488d
Cleared Apr 21, 1998
SLT CL MD CONTACT LASER SYSTEM
K972548 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 287d
Cleared Apr 21, 1998
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K973896 · BSZ
Ohmeda Medical
Anesthesiology · 189d
Cleared Apr 21, 1998
DENTEK LD 15 LASERSYSTEM
K974057 · GEX
Dentek Lasersystems Produktions...
General & Plastic Surgery · 176d
Cleared Apr 21, 1998
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
K974371 · LYY
Clk Intl., Inc.
General Hospital · 152d
Cleared Apr 21, 1998
ACKERMANN SURGICAL INSTRUMENTS
K974382 · GCJ
Ackermann Instrumente GmbH
General & Plastic Surgery · 151d
Cleared Apr 21, 1998
OPTICAL TRACKING SYSTEM (OTS)
K974602 · HAW
Radionics Software Applications, Inc.
Neurology · 133d
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · LTJ
Diagnostic Products Corp.
Immunology · 118d