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
151777–151800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1984
COBE AEPS
K842054 · KRL
Cobe Laboratories, Inc.
Cardiovascular · 72d
Cleared Aug 02, 1984
ASCORBIC ACID
K842215 · FIP
Organon Teknika Corp.
Gastroenterology & Urology · 59d
Cleared Aug 02, 1984
PARTIALLY THREADED BONE FIX. PIN
K842293 · JDW
Warsaw Orthopedic, Inc.
Orthopedic · 50d
Cleared Aug 02, 1984
ULTRA LYTE ANALYZER I 100
K842315 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY KIT
K842326 · DFH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · DFT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · DEW
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330 · CZP
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAPEUTIC EXER EQUIP-
K842429 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAP. EXERCISE EQUIP
K842430 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAPEUTIC EXERCISE
K842433 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
DISPOSABLE SURGERY HOOD
K842438
Anago, Inc.
General & Plastic Surgery · 42d
Cleared Aug 02, 1984
DISPOSABLE PREPING PAD
K842453
Anago, Inc.
General & Plastic Surgery · 41d
Cleared Aug 02, 1984
GX CEPH
K842463 · EAG
Gendex Corp.
Radiology · 41d
Cleared Aug 02, 1984
SURGICAL HEADLIGHT
K842515 · EBA
Good-Lite Co.
Dental · 51d
Cleared Aug 02, 1984
PDA SYSTEM
K842522 · JJG
Abbott Laboratories
Chemistry · 36d
Cleared Aug 02, 1984
BASE METAL ALLOY
K842551 · EJH
Dentsply Intl.
Dental · 31d
Cleared Aug 02, 1984
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · LJP
Syva Co.
Microbiology · 28d
Cleared Aug 02, 1984
GENETIC SYS LEGIONELLA IMMUNOFLURORES
K842683 · LHL
Genetic Systems Corp.
Immunology · 23d
Cleared Aug 02, 1984
ISLAM BONE MARROW ASPIRATION NEEDLES
K842699 · GAA
Downs Surgical , Ltd.
General & Plastic Surgery · 22d
Cleared Aug 02, 1984
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU
K842701 · FZS
Downs Surgical , Ltd.
General & Plastic Surgery · 22d
Cleared Aug 02, 1984
ROSENBERG SKIN GRAFTING KNIVES
K842702 · GFD
Downs Surgical , Ltd.
General & Plastic Surgery · 22d
Cleared Aug 02, 1984
MONTG. LARYNGEAL KEEL
K842800 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 16d
Cleared Aug 02, 1984
CHERMEL BONE GOUGES
K842822 · GDH
Cher Mel Corp.
General & Plastic Surgery · 14d