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
136105–136128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875371 · HGL
Kontron Instruments, Inc.
Obstetrics & Gynecology · 84d
Cleared Mar 24, 1988
STA-SET I.V. FLOW REGULATOR
K880006 · LDR
Controlled Flow , Ltd.
General Hospital · 80d
Cleared Mar 24, 1988
EBV-NA TEST
K880043 · LLM
Gull Laboratories, Inc.
Microbiology · 78d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070 · JHI
Abbott Laboratories
Chemistry · 72d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
K880170 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 69d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 69d
Cleared Mar 24, 1988
THEOPHYLLINE TEST KIT REF. #A874799
K880291 · LCA
Photec Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
K880296 · CFT
London Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · CEK
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313 · CIX
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
K880452 · GZJ
Lumiscope Co., Inc.
Neurology · 51d
Cleared Mar 24, 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467 · JIY
Stanbio Laboratory
Chemistry · 50d
Cleared Mar 24, 1988
WORD BARTHOLIN GLAND CATHETER CODE: 1005
K880497 · KNA
Hoosier Specialties, Inc.
Obstetrics & Gynecology · 48d
Cleared Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546 · JMO
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Mar 24, 1988
UTILITY WAX STRIPS, CINNAMON
K880606 · EGD
Columbus Dental Mfg. Co.
Dental · 41d
Cleared Mar 24, 1988
UNIMETER CALIBRATION KIT
K880610 · JIW
Boehringer Mannheim Corp.
Chemistry · 41d
Cleared Mar 24, 1988
EMIT THYROXINE ASSAY
K880620 · KLI
Syva Co.
Chemistry · 37d
Cleared Mar 24, 1988
PARAMAX AMMONIA REAGENT
K880651 · JIF
Baxter Healthcare Corp
Chemistry · 36d
Cleared Mar 24, 1988
INORGANIC PHOSPHORUS REAGENT SET
K880676 · CEO
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
TOTAL PROTEIN REAGENT SET
K880677 · CEK
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · CGR
Amersham Corp.
Chemistry · 31d
Cleared Mar 24, 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · JJT
Quantimetrix Corp.
Chemistry · 31d
Cleared Mar 24, 1988
PROTEIN BASE ISE CONTROL
K880710 · JJR
Bionostics, Inc.
Chemistry · 31d
Cleared Mar 24, 1988
WAKO AUTOKIT URIC ACID
K880731 · KNK
Wako Chemicals USA, Inc.
Chemistry · 29d