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
130801–130824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1989
ESPE CAPMIX
K891064 · EFD
Espe GmbH (Us)
Dental · 90d
Cleared May 30, 1989
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · BSS
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 85d
Cleared May 30, 1989
VASCULAR ACCESS PORT CONTINUOUS INFUSION SET
K891226 · FPA
Infucare Products, Inc.
General Hospital · 84d
Cleared May 30, 1989
ARGEDENT 52 (DENTAL ALLOY)
K891989 · EJT
Argen Precious Metals, Inc.
Dental · 63d
Cleared May 30, 1989
NEEDLEPOINT GUARD
K892405 · FMF
Urological Assoc. of Grand Island, P.C.
General Hospital · 53d
Cleared May 26, 1989
GENESIS TM FETAL SYSTEM
K882084 · HGM
Pediatric Diagnostic Service
Obstetrics & Gynecology · 373d
Cleared May 26, 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794 · LWJ
Protek, Inc.
Orthopedic · 261d
Cleared May 26, 1989
ACUDATA INDICATENS MODEL 5X
K890088 · GZJ
Acudata Software
Neurology · 136d
Cleared May 26, 1989
JUMPER PACK #203
K890825 · HQC
O.R. Specialties, Inc.
Ophthalmic · 98d
Cleared May 26, 1989
ESPE TULUX-CEM
K891020 · EBF
Espe GmbH (Us)
Dental · 87d
Cleared May 26, 1989
TEMPTEK 5010 THERMAL COOLING BLANKET
K891092 · ILO
Temptek, Inc.
Physical Medicine · 85d
Cleared May 26, 1989
VITRECTOMY PACK #J120
K891161 · HQC
O.R. Specialties, Inc.
Ophthalmic · 81d
Cleared May 26, 1989
LEUCOPREP CELL SEPARATION TUBE
K891407 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 73d
Cleared May 26, 1989
STERILE BURNNET PRE-CUT (VARIOUS SIZES)
K891459 · NAD
Western Medical, Ltd.
General & Plastic Surgery · 72d
Cleared May 26, 1989
LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS
K891909 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 60d
Cleared May 26, 1989
ORTHO-J, INC. BEK-JS-004
K891917 · JEB
Ortho-J, Inc.
General & Plastic Surgery · 60d
Cleared May 26, 1989
MAGNILINK SYSTEM 101
K892347 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 201
K892348 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 209
K892349 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 402/5
K892350 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 602
K892351 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
COMFORTRAC, CT90 & CT100 BI-PHASICS
K892669 · ISA
Comfortrac Systems
Physical Medicine · 43d
Cleared May 26, 1989
ANGIOTEC ZX DIGITAL IMAGE PROCESSOR
K892869 · LLZ
Andros Analyzers, Inc.
Radiology · 37d
Cleared May 26, 1989
PROXIMATE LINEAR CUTTER THICK TISSUE INST.
K892927 · GAG
Ethicon, Inc.
General & Plastic Surgery · 35d