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
136081–136104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1988
CALCOFLUOR WHITE STAIN KIT
K880718 · JTS
Remel Co.
Pathology · 31d
Cleared Mar 25, 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730 · DCK
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
NOVA LITE(TM) ANA
K880736 · LLL
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
NOVA LITE(TM) DSDNA
K880742 · DHN
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
K880828 · DFT
Wako Chemicals USA, Inc.
Immunology · 24d
Cleared Mar 25, 1988
NOVA GEL(TM) SS-A/SS-B
K880896 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Mar 25, 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · KYZ
Micromedics, Inc.
General Hospital · 15d
Cleared Mar 25, 1988
OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
K881060 · JEA
Orthopedic Systems, Inc.
General & Plastic Surgery · 21d
Cleared Mar 25, 1988
UTILITY CLAMP
K881084 · GDJ
Med-Dex Intl.
General & Plastic Surgery · 11d
Cleared Mar 24, 1988
VITAACCESS (TM) CATHETER INTRODUCER SYSTEM
K872998 · FOZ
Vitaphore Corp.
General Hospital · 234d
Cleared Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 1112
K873820 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
GE NORYL 731-80089S
K873821 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
MOBAY (BAYER) MERLON M-40 (H)F 1112
K873822 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 3291
K873823 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
K873824 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
GE LEXAN 144R 112
K873825 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
INET MODEL BIOVISION
K873834 · HCC
Inet Corp.
Neurology · 185d
Cleared Mar 24, 1988
LARYNGECTOMY TUBE
K873992 · KAC
Portex, Inc.
Ear, Nose, Throat · 175d
Cleared Mar 24, 1988
MEDCO MEMORY RETRACTOR SYSTEM
K874829 · GZT
Medical Equipment Development Co., Inc.
Neurology · 121d
Cleared Mar 24, 1988
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
K874875 · CEC
Boots-Celltech Diagnostics, Inc.
Chemistry · 118d
Cleared Mar 24, 1988
WESBLOT PROCESSOR
K874887 · KPA
American Bionetics, Inc.
Chemistry · 114d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875334 · HGL
Kontron Instruments, Inc.
Obstetrics & Gynecology · 85d
Cleared Mar 24, 1988
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K875350 · BSZ
Ohmeda Medical
Anesthesiology · 84d